Event Programme

19 November - 22 November

Day 1

Pharmtech & Ingredients Official Opening Ceremony

19 November

10:30 - 11:00

Presentation Zone A, Hall 7, Pavillion 2


Add to calendar 11/19/2019 10:30 11/19/2019 11:00 Official Opening Ceremony Presentation Zone A, Hall 7, Pavillion 2 Europe/Moscow

Ceremony

Official Opening Ceremony

Round table discussion: Total readiness for medicine labelling

Place: Presentation Zone A, Hall 7, Pavillion 2
Participation: free, electronic ticket based
Language: Russian

Co-organiser: Association of Russian Pharmaceutical Manufacturers (ARFP)
 
The event is dedicated to the implementation of the key national project of monitoring the movement of medicines and launching universal medicine labelling from 1 January 2020.
 
The session will cover issues related to the readiness of all parties involved in distributing medicines, the efficiency of the information system for monitoring the movement of medicines, as well as the initial results of labelling and traceability of medicines included in Russia’s Seven Nosologies Programme.

19 November

12:00 - 14:00

Presentation Zone A, Hall 7, Pavillion 2


Add to calendar 11/19/2019 12:00 11/19/2019 14:00 Total readiness for medicine labelling More speakers details>>
 
Presentation Zone A, Hall 7, Pavillion 2 Europe/Moscow

Round table

Total readiness for medicine labelling

More speakers details>>
 

Moderators

Victor Dmitriyev
CEO , Association of the Russian pharmaceutical manufacturers

Speakers

Alexey Alekhin*
Head of Department of pharmaceutical and medical industry development , Ministry of Industry and Trade
Anatoliy Tentser
Head of Business Development , Katren Group
Dmitry Alkhazov
General Director , CRPT
Evgenii Nifantev
Coordinating Council , Russian Association of Pharmacy Chains Chairman
Margarita Mustafina
Project Lead , Teva LLC
Mikhail Ignatov
Head of the Pharmacy Department , Moscow Department of Health
Mikhail Murashko
Head , Federal Service for Surveillance in Healthcare
Valentina Kosenko
Deputy Head , Federal Service for Surveillance in Healthcare
Vladimir Anikeev
Adviser Director General , BIOCAD
Vladimir Shipkov
Executive Director , Association of international pharmaceutical manufacturers

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Round table discussion: Export potential: new growth points

Place: Presentation Zone A, Hall 7, Pavillion 2
Participation: free, electronic ticket based
Language: Russian

Co-organiser: GMP News

Questions for discustion:

1. State measures of support and targets for exporting pharmaceutical products
2. Prospects for developing the Eurasian Economic Union’s pharmaceutical market. Integrating the union into the international trade system
3. Measures for supporting exports as part of the International Cooperation and Export national project
4. Promising export markets and mechanisms to overcome regulatory barriers
5. Operational schemes and creating entry points to international markets: case studies from Russian and international companies
 

19 November

15:00 - 17:00

Presentation Zone A, Hall 7, Pavillion 2


Add to calendar 11/19/2019 15:00 11/19/2019 17:00 Export potential: new growth points More speaker details>> Presentation Zone A, Hall 7, Pavillion 2 Europe/Moscow

Round table

Export potential: new growth points

More speaker details>>

Moderators

Irina Novikova
Executive Director , MEDIA-PHARM NEWS

Speakers

Alexey Alekhin*
Head of Department of pharmaceutical and medical industry development , Ministry of Industry and Trade
Dmitry Borisov
Commercial Director , STPF POLYSAN
Dmitry Chagin
Chairman of the Board , EAEU Pharmaceutical Manufacturing Association
Ilya Vesker*
Director of Market Product and Patient Support Programmers , Takeda Pharmaceutical
Irina Kashirina
Project Director of the medical and pharmaceutical industry export promotion , Russian Export Center
Ivan Glushkov
Deputy General Director , STADA CIS
Vladislav Shestakov
Director , FSI "State Institute of Drugs and God Practices"
Yuri Petrosyan
Director for Export to the CIS Countries, Asia, ASEAN , Pharmasyntez Group of Companies

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Seminars - November, 19

19 November

11:00 - 13:00

Prezentation Zone B, Hall 8, Pavillion 2


Add to calendar 11/19/2019 11:00 11/19/2019 13:00 Seminar by Gluvex: Discussion area: Engineering problems. Yesterday, today, tomorrow Prezentation Zone B, Hall 8, Pavillion 2 Europe/Moscow

Seminars

Seminar by Gluvex: Discussion area: Engineering problems. Yesterday, today, tomorrow

19 November

13:10 - 14:10

Prezentation Zone B, Hall 8, Pavillion 2


Add to calendar 11/19/2019 13:10 11/19/2019 14:10 Seminar by Lonza: Innovative solutions from Lonza for healthcare industry
Hard empty capsules from various polymers, R&D services, innovative API development, specialized equipment, ready products as OTC and DS
Prezentation Zone B, Hall 8, Pavillion 2 Europe/Moscow

Seminars

Seminar by Lonza: Innovative solutions from Lonza for healthcare industry

Hard empty capsules from various polymers, R&D services, innovative API development, specialized equipment, ready products as OTC and DS

19 November

14:20 - 15:20

Prezentation Zone B, Hall 8, Pavillion 2


Add to calendar 11/19/2019 14:20 11/19/2019 15:20 Seminar by Swiss Business Hub Russia: Swiss innovative technologies in the pharmaceutical production and packaging industry Prezentation Zone B, Hall 8, Pavillion 2 Europe/Moscow

Seminars

Seminar by Swiss Business Hub Russia: Swiss innovative technologies in the pharmaceutical production and packaging industry

Day 2

Discussion session: An effective view on technical support for medicines production

Place: Presentation Zone A, Hall 7, Pavillion 2
Participation: free, electronic ticket based
Language: Russian

Co-organiser: FPT 

Moderator: Grigoriy Peglivanyan, FPT, CEO

Due to the current state of the Russian economy and the decline in purchasing power of medicine users, manufacturers need to take action as soon as possible. Improving operational efficiency is becoming one of the most important tasks in the fight for profitability. Suppliers of equipment and services are also required to respond to this challenge and offer appropriate tools.
Participants of this session will discuss the issue of efficiency at different stages of a pharmaceutical enterprise’s life cycle. Issues of effective manufacturing engineering, including capital and operating costs, operational efficiency and ways to improve it will be discussed. Special attention will be paid to innovative solutions that improve efficiency at different stages of production.

20 November

11:00 - 13:30

Presentation Zone A, Hall 7, Pavillion 2


Add to calendar 11/20/2019 11:00 11/20/2019 13:30 An effective view on technical support for medicines production Due to the current state of the Russian economy and the decline in purchasing power of medicine users, manufacturers need to take action as soon as possible. Improving operational efficiency is becoming one of the most important tasks in the fight for profitability. Suppliers of equipment and services are also required to respond to this challenge and offer appropriate tools.
Participants of this session will discuss the issue of efficiency at different stages of a pharmaceutical enterprise’s life cycle. Issues of effective manufacturing engineering, including capital and operating costs, operational efficiency and ways to improve it will be discussed. Special attention will be paid to innovative solutions that improve efficiency at different stages of production.
Representatives of the manufacturers of technological equipment and medicines - BWT, Marchesini, IMA, FPT – are invited.
Presentation Zone A, Hall 7, Pavillion 2 Europe/Moscow

Discussion session

An effective view on technical support for medicines production

Due to the current state of the Russian economy and the decline in purchasing power of medicine users, manufacturers need to take action as soon as possible. Improving operational efficiency is becoming one of the most important tasks in the fight for profitability. Suppliers of equipment and services are also required to respond to this challenge and offer appropriate tools.
Participants of this session will discuss the issue of efficiency at different stages of a pharmaceutical enterprise’s life cycle. Issues of effective manufacturing engineering, including capital and operating costs, operational efficiency and ways to improve it will be discussed. Special attention will be paid to innovative solutions that improve efficiency at different stages of production.
Representatives of the manufacturers of technological equipment and medicines - BWT, Marchesini, IMA, FPT – are invited.

20 November

11:00 - 13:30

Presentation Zone A, Hall 7, Pavillion 2


Add to calendar 11/20/2019 11:00 11/20/2019 13:30 The processes combination in the SDF production as the basis for highly efficient production Presentation Zone A, Hall 7, Pavillion 2 Europe/Moscow

Discussion session

The processes combination in the SDF production as the basis for highly efficient production

Speakers

Explore

20 November

11:00 - 13:30

Presentation Zone A, Hall 7, Pavillion 2


Add to calendar 11/20/2019 11:00 11/20/2019 13:30 Digital Reality is Already Here. Industry 4.0. How do smart machines influence efficiency of production? More speaker details>> Presentation Zone A, Hall 7, Pavillion 2 Europe/Moscow

Discussion session

Digital Reality is Already Here. Industry 4.0. How do smart machines influence efficiency of production?

More speaker details>>

Speakers

Angelica Kosinova
Head of projects , Marchesini Group Rus
Federico Finotti
Commercial Director , Sea Vision Rus

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20 November

11:00 - 13:30

Presentation Zone A, Hall 7, Pavillion 2


Add to calendar 11/20/2019 11:00 11/20/2019 13:30 Effectiveness of Clean utilities and Solution preparation systems at each stage of life cycle Presentation Zone A, Hall 7, Pavillion 2 Europe/Moscow

Discussion session

Effectiveness of Clean utilities and Solution preparation systems at each stage of life cycle

Speakers

Sergey Movsesov
Head of Pharmaceutical Division , BWT Russia

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20 November

11:00 - 13:30

Presentation Zone A, Hall 7, Pavillion 2


Add to calendar 11/20/2019 11:00 11/20/2019 13:30 10 life hacks to increase efficiency at the pharmaceutical production construction phase Presentation Zone A, Hall 7, Pavillion 2 Europe/Moscow

Discussion session

10 life hacks to increase efficiency at the pharmaceutical production construction phase

Speakers

Explore

20 November

11:00 - 13:30

Presentation Zone A, Hall 7, Pavillion 2


Add to calendar 11/20/2019 11:00 11/20/2019 13:30 PAT tools can actually improve effectiveness in OSD production More speaker details>> Presentation Zone A, Hall 7, Pavillion 2 Europe/Moscow

Discussion session

PAT tools can actually improve effectiveness in OSD production

More speaker details>>

Speakers

Carlo Tenore
Product Manager OSD , IMA ACTIVE
Dmitry Koryagin
Sales Manager Russia and CIS , IMA EST

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20 November

11:00 - 13:30

Presentation Zone A, Hall 7, Pavillion 2


Add to calendar 11/20/2019 11:00 11/20/2019 13:30 Boosting productivity with Uhlmann Tool Management Presentation Zone A, Hall 7, Pavillion 2 Europe/Moscow

Discussion session

Boosting productivity with Uhlmann Tool Management

Speakers

David Haug
Digital Solutions Consultant , UHLMANN

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20 November

11:00 - 13:30

Presentation Zone A, Hall 7, Pavillion 2


Add to calendar 11/20/2019 11:00 11/20/2019 13:30 Methods of production efficiency improvement Presentation Zone A, Hall 7, Pavillion 2 Europe/Moscow

Discussion session

Methods of production efficiency improvement

Speakers

Andrey Stukan
manager on efficiency and thrifty production , FPT

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Round table discussion: API production: the economic aspect

Place: Presentation Zone A, Hall 7, Pavillion 2
Participation: free, electronic ticket based
Language: Russian

Despite the decline in the supply of active pharmaceutical ingredients over recent years, financially, imports of APIs continue to grow. One of the key objectives of the Pharma 2030 programme is to provide the pharmaceutical industry with enough in terms of stock and quantity locally produced raw materials, primarily pharmaceutical substances. But there are factors that hinder the production growth of locally produced substances, the main one being the need for large investments, high material intensity and energy intensity of substance production. On the other hand, the resolution regulating public procurement of medicines, which came into force on 1 January 2019, introduced a new type of state support — a price preference of 25% of the minimum contract price. It will apply only to those companies that produce medicines in Russia and the EAEU countries on a full cycle, from the synthesis of the substance to packaging.
How can companies producing their own substances work according to the resolution and what economic benefits they can give? These and other issues will be discussed at the round table discussion API production: the economic aspect, on 20 November at Pharmtech & Ingredients.
Speakers will include representatives of regulatory bodies, leading industry experts, and representatives of API manufacturing companies.

 

20 November

14:30 - 16:30

Presentation Zone A, Hall 7, Pavillion 2


Add to calendar 11/20/2019 14:30 11/20/2019 16:30 API production: the economic aspect More speaker details>> Presentation Zone A, Hall 7, Pavillion 2 Europe/Moscow

Round table

API production: the economic aspect

More speaker details>>

Moderators

Ivan Glushkov
Deputy General Director , STADA CIS

Speakers

Alexander Semenov
President , Acticomp, JSC
Alexey Alekhin*
Head of Department of pharmaceutical and medical industry development , Ministry of Industry and Trade
Georgy Khachiyan
General Director , REATORG LLC
Konstantin Perov
chief consultant, P.H.D. , InKonTech
Ludmila Scherbakova
Head of Group of Companies , Bright Way
Ratmir Dashkin
CEO , "Mendeleev Engineering Center", LLC
Yuri Sanakoev
Quality Director , BION
Zakhar Golant
General Director , Baltpharma

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Seminars - November, 20

20 November

11:00 - 12:00

Prezentation Zone B, Hall 8, Pavillion 2


Add to calendar 11/20/2019 11:00 11/20/2019 12:00 Seminar by Asahi Kasei Bioprocess Europe: PLANOVA Virus Removal Filters Prezentation Zone B, Hall 8, Pavillion 2 Europe/Moscow

Seminars

Seminar by Asahi Kasei Bioprocess Europe: PLANOVA Virus Removal Filters

20 November

12:10 - 14:10

Prezentation Zone B, Hall 8, Pavillion 2


Add to calendar 11/20/2019 12:10 11/20/2019 14:10 Seminar by GEA: Centrifuges and package units from GEA for human and veterinary vaccines, starter cultures production, human Blood Plasma Protein fractionation Prezentation Zone B, Hall 8, Pavillion 2 Europe/Moscow

Seminars

Seminar by GEA: Centrifuges and package units from GEA for human and veterinary vaccines, starter cultures production, human Blood Plasma Protein fractionation

20 November

14:20 - 16:20

Prezentation Zone B, Hall 8, Pavillion 2


Add to calendar 11/20/2019 14:20 11/20/2019 16:20 Seminar by PALL: Regulatory Compliance. Are you up-to-date with the latest GMP requirements and biopharmaceutical industry best practices? Prezentation Zone B, Hall 8, Pavillion 2 Europe/Moscow

Seminars

Seminar by PALL: Regulatory Compliance. Are you up-to-date with the latest GMP requirements and biopharmaceutical industry best practices?

Pharmtechprom forum - November, 20

Date: November, 20-21 
Place: Conference Hall L, Hall 7, Pavillion 2
Participation: free, electronic ticket based
Language: Russian

Download the forum programme>>

20 November

10:00 - 13:30

Session A – Raw materials and pharmaceutical ingredients. Moderator: Sergey Skvortsov, Elementoorganika (Russia), Managing Director

20 November

10:00 - 10:25

Registration of participants

20 November

10:30 - 11:00

Conference Hall L, Hall 7, Pavillion 2


Add to calendar 11/20/2019 10:30 11/20/2019 11:00 Liquid and soft drugs formulation development with Super Refined excipients, eliminating instability and impurities issues
  1. Impurities formation in drug formulation
  2. Excipient instability and review of some decomposition products
  3. Impurities influence on API stability
  4. Advantages of drug formulation development driven by Super Refined excipients
Conference Hall L, Hall 7, Pavillion 2 Europe/Moscow

Session A – Raw materials and pharmaceutical ingredients

Liquid and soft drugs formulation development with Super Refined excipients, eliminating instability and impurities issues

  1. Impurities formation in drug formulation
  2. Excipient instability and review of some decomposition products
  3. Impurities influence on API stability
  4. Advantages of drug formulation development driven by Super Refined excipients

Speakers

Olesya Vereschagina
Life Science Sales Representative , LLC Croda RUS

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20 November

11:05 - 11:35

Conference Hall L, Hall 7, Pavillion 2


Add to calendar 11/20/2019 11:05 11/20/2019 11:35 Pharmaceutical ingredients: optimization of production from press to coater Oral Solid Dosage (OSD) form became increasingly popular in the modern world due to its portability, ease of administration and benefit of creating a formulation even with ingredients which are poorly compatible. However, composition of solid dosage formulation is often quite challenging when it comes to pharmaceutical technology. Therefore, formulators usually face the following questions:
• How to formulate a robust OSD?
• How to achieve uniformity and optimal compactability of tablet mass?
• Which filler is the best for hard gelatin capsules?
• How to switch from wet granulation to direct compression painlessly?
• How to prepare an in-house coating solution to decrease production cost price? Is it possible to prepare functional in-house coatings?
• How to rationally compose an ODT formulation?
In this presentation we will discuss all those questions and even more. The information received will help you optimize the process of manufacturing OSD, therefore you may decrease cost prices and make life easier for you and your company.
Conference Hall L, Hall 7, Pavillion 2 Europe/Moscow

Session A – Raw materials and pharmaceutical ingredients

Pharmaceutical ingredients: optimization of production from press to coater

Oral Solid Dosage (OSD) form became increasingly popular in the modern world due to its portability, ease of administration and benefit of creating a formulation even with ingredients which are poorly compatible. However, composition of solid dosage formulation is often quite challenging when it comes to pharmaceutical technology. Therefore, formulators usually face the following questions:
• How to formulate a robust OSD?
• How to achieve uniformity and optimal compactability of tablet mass?
• Which filler is the best for hard gelatin capsules?
• How to switch from wet granulation to direct compression painlessly?
• How to prepare an in-house coating solution to decrease production cost price? Is it possible to prepare functional in-house coatings?
• How to rationally compose an ODT formulation?
In this presentation we will discuss all those questions and even more. The information received will help you optimize the process of manufacturing OSD, therefore you may decrease cost prices and make life easier for you and your company.

Speakers

Alexandra Voskoboynikova
Deputy General Director for International Economic Activity , CJSC FPK PharmVILAR

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20 November

11:40 - 12:10

Conference Hall L, Hall 7, Pavillion 2


Add to calendar 11/20/2019 11:40 11/20/2019 12:10 Development of mucoadhesive drug delivery systems with Carbopols

Mucoadhesive dosage forms can be designed to provide long-term retention at contact point, providing a controlled release of APIs to improve the therapeutic result. Among the most effective excipients with stable mucoadhesive properties are the Carbopol™ carbomers manufactured by Lubrizol. These substances are high molecular weight polymers of acrylic acid chemically cross-linked with polyalkenyl alcohols or divinyl glycol.

Conference Hall L, Hall 7, Pavillion 2 Europe/Moscow

Session A – Raw materials and pharmaceutical ingredients

Development of mucoadhesive drug delivery systems with Carbopols

Mucoadhesive dosage forms can be designed to provide long-term retention at contact point, providing a controlled release of APIs to improve the therapeutic result. Among the most effective excipients with stable mucoadhesive properties are the Carbopol™ carbomers manufactured by Lubrizol. These substances are high molecular weight polymers of acrylic acid chemically cross-linked with polyalkenyl alcohols or divinyl glycol.

Speakers

Engin Sari
European technical product manager , IMCD

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20 November

12:15 - 12:45

Conference Hall L, Hall 7, Pavillion 2


Add to calendar 11/20/2019 12:15 11/20/2019 12:45 Formulators’ tools to meet the requirements of contemporary drugs development When developing generic drugs, especially solid dosage forms, formulators face two conflicting tasks: to provide the market demand (quality and/or price) and make the development in a way of copy-paste. But how often these copy-paste formulations meet the market demands? Not very often.
What tools formulators have to meet both conflicting parties. How to meet the demands of the market and development.
Conference Hall L, Hall 7, Pavillion 2 Europe/Moscow

Session A – Raw materials and pharmaceutical ingredients

Formulators’ tools to meet the requirements of contemporary drugs development

When developing generic drugs, especially solid dosage forms, formulators face two conflicting tasks: to provide the market demand (quality and/or price) and make the development in a way of copy-paste. But how often these copy-paste formulations meet the market demands? Not very often.
What tools formulators have to meet both conflicting parties. How to meet the demands of the market and development.

Speakers

Renat Kashapov
API and formulation manager , Merck

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20 November

12:50 - 13:20

Conference Hall L, Hall 7, Pavillion 2


Add to calendar 11/20/2019 12:50 11/20/2019 13:20 Digital assistant for formulation development
Currently, drug product development is based on empirical methods; the outcome often depends on the expertise and intuition of individual formulators. As a result, the development process can be time-intensive, costly, and has a high risk of failure. To lower the risk of failure and reduce the number of time-consuming and costly lab experiments, BASF has developed a science-based formulation prediction system that enables specialists to design robust drug formulations. Such system will be presented for the first time in Russia at Pharmtechprom forum.
Conference Hall L, Hall 7, Pavillion 2 Europe/Moscow

Session A – Raw materials and pharmaceutical ingredients

Digital assistant for formulation development

Currently, drug product development is based on empirical methods; the outcome often depends on the expertise and intuition of individual formulators. As a result, the development process can be time-intensive, costly, and has a high risk of failure. To lower the risk of failure and reduce the number of time-consuming and costly lab experiments, BASF has developed a science-based formulation prediction system that enables specialists to design robust drug formulations. Such system will be presented for the first time in Russia at Pharmtechprom forum.

Speakers

Nadezhda Romanova
Technical Sales Representative , BASF

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20 November

13:20 - 13:30

Discussion

20 November

13:30 - 14:00

Networking break

20 November

14:00 - 17:00

Session B – Technologies and equipment for pharmaceutical production. N. Pyatigorskaya, I.M. Sechenov First Moscow State Medical University, Head of Chair of Industrial Pharmacy, Pharm. D., Prof.

20 November

14:00 - 14:30

Conference Hall L, Hall 7, Pavillion 2


Add to calendar 11/20/2019 14:00 11/20/2019 14:30 Isolators for Chemical and Pharmaceuticals application: Process Equipment integration into HPAPI’s containment system Today the request of handling toxic compound in safe way is becoming more and more actual. From Charging reactors and preparation vessels to final packaging/filling operations the attention to operator safety and product protection has to be taken in consideration by using the right technology. Using rigid Isolators in most of the case is the only available solution to achieve both operator safety by process containment and product protection. The presentation is giving right indication in order to be able to select the proper containment system in function of the real necessity. Some case studies are also presented to show the state of the art and latest innovation in this field. Conference Hall L, Hall 7, Pavillion 2 Europe/Moscow

Session B – Technologies and equipment for pharmaceutical production

Isolators for Chemical and Pharmaceuticals application: Process Equipment integration into HPAPI’s containment system

Today the request of handling toxic compound in safe way is becoming more and more actual. From Charging reactors and preparation vessels to final packaging/filling operations the attention to operator safety and product protection has to be taken in consideration by using the right technology. Using rigid Isolators in most of the case is the only available solution to achieve both operator safety by process containment and product protection. The presentation is giving right indication in order to be able to select the proper containment system in function of the real necessity. Some case studies are also presented to show the state of the art and latest innovation in this field.

Speakers

Stefano Butti
директор по продажам , F.P.S. Food and Pharma Systems srl

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20 November

14:35 - 15:05

Conference Hall L, Hall 7, Pavillion 2


Add to calendar 11/20/2019 14:35 11/20/2019 15:05 Gentle processing of ampoules and vials: One machine fits all Which general and upcoming trends are influencing sterile ampoule and vial filling and processing?
Which technical solutions are needed to meet these trends and to process liquid containers in an adequate and secure way?
Let´s have a deeper look on:
  • High speed processing
  • In-Line inspection
  • 100% In Process control
  • Flexibiltiy of filling systems
  • Minimizing of product loss
Conference Hall L, Hall 7, Pavillion 2 Europe/Moscow

Session B – Technologies and equipment for pharmaceutical production

Gentle processing of ampoules and vials: One machine fits all

Which general and upcoming trends are influencing sterile ampoule and vial filling and processing?
Which technical solutions are needed to meet these trends and to process liquid containers in an adequate and secure way?
Let´s have a deeper look on:

  • High speed processing
  • In-Line inspection
  • 100% In Process control
  • Flexibiltiy of filling systems
  • Minimizing of product loss

Speakers

Tobias Göttler
Global Product Manager Liquid Filling Technologies , Robert Bosch Packaging Technology GmbH

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20 November

15:10 - 15:40

Conference Hall L, Hall 7, Pavillion 2


Add to calendar 11/20/2019 15:10 11/20/2019 15:40 Handling from Powder and Liquid in the Pharmacy Mueller Systems is a leading manufacturer of stainless-steel containers, stainless steel drums and handling equipment, offering innovative solutions and the highest quality standards. Alongside perfecting stainless-steel drums, hoppers, silos and special stainless-steel containers together with stationary and mobile handling equipment for technical processing applications in various industrial areas. MCS cleaning systems are characterized by a definable cleaning and drying process.
 
Müller handling equipment figures:
– Stable, lightweight and durable
– Capacity: from 0,1 L to 2000 L
- Diameter: from 80 mm to 1200 mm
– Lidded drums and drums with bungs, cylindrical and conical
– Polished surfaces for optimum product discharge
– GMP pharmaceutical standard
– Modular design
 
The presentation will give the different types of containers for storage and transportation of liquids and powders offered by Müller, their characteristics and advantages of use.
Conference Hall L, Hall 7, Pavillion 2 Europe/Moscow

Session B – Technologies and equipment for pharmaceutical production

Handling from Powder and Liquid in the Pharmacy

Mueller Systems is a leading manufacturer of stainless-steel containers, stainless steel drums and handling equipment, offering innovative solutions and the highest quality standards. Alongside perfecting stainless-steel drums, hoppers, silos and special stainless-steel containers together with stationary and mobile handling equipment for technical processing applications in various industrial areas. MCS cleaning systems are characterized by a definable cleaning and drying process.
 
Müller handling equipment figures:
– Stable, lightweight and durable
– Capacity: from 0,1 L to 2000 L
- Diameter: from 80 mm to 1200 mm
– Lidded drums and drums with bungs, cylindrical and conical
– Polished surfaces for optimum product discharge
– GMP pharmaceutical standard
– Modular design
 
The presentation will give the different types of containers for storage and transportation of liquids and powders offered by Müller, their characteristics and advantages of use.

Speakers

Jakob Jenner
Area Sales Manager , MÜLLER GmbH

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20 November

15:45 - 16:15

Conference Hall L, Hall 7, Pavillion 2


Add to calendar 11/20/2019 15:45 11/20/2019 16:15 Suspension adaptation and process development of Multipotent Mesenchymal Stem Cells for cell therapy applications Human mesenchymal stem cells (hMSCs) have great potential as cellular therapeutics due to their ability to differentiate towards multiple lineages. Possible applications range from the treatment of Crohn’s disease to graft versus host disease and also target cardiovascular conditions among others.
To date, the generation of large numbers of hMSCs is typically achieved using two dimensional (2D) tissue culture vessels. However, this culturing approach requires a high level of operator manipulation and offers little in the way of culture control. A possible solution is the scale-up and large-scale production of hMSCs in three dimension (3D) culture on microcarriers utilizing stirred tank bioreactors. Here we demonstrate the utility of the ambr15 and ambr250 modular stirred tank bioreactor systems as valuable tools for hMSC process development and optimization paving the way for the large-scale production of clinically relevant numbers of hMSCs.
Conference Hall L, Hall 7, Pavillion 2 Europe/Moscow

Session B – Technologies and equipment for pharmaceutical production

Suspension adaptation and process development of Multipotent Mesenchymal Stem Cells for cell therapy applications

Human mesenchymal stem cells (hMSCs) have great potential as cellular therapeutics due to their ability to differentiate towards multiple lineages. Possible applications range from the treatment of Crohn’s disease to graft versus host disease and also target cardiovascular conditions among others.
To date, the generation of large numbers of hMSCs is typically achieved using two dimensional (2D) tissue culture vessels. However, this culturing approach requires a high level of operator manipulation and offers little in the way of culture control. A possible solution is the scale-up and large-scale production of hMSCs in three dimension (3D) culture on microcarriers utilizing stirred tank bioreactors. Here we demonstrate the utility of the ambr15 and ambr250 modular stirred tank bioreactor systems as valuable tools for hMSC process development and optimization paving the way for the large-scale production of clinically relevant numbers of hMSCs.

Speakers

Quentin Vicard
MSC & MBA Technology Expert Regenerative Medicine , Sartorius Stedim France

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20 November

16:20 - 16:50

Conference Hall L, Hall 7, Pavillion 2


Add to calendar 11/20/2019 16:20 11/20/2019 16:50 High-throughput glycan screening of crude and purified samples Glycosylation is considered among the most important post-translational modifications when developing new biologics. Having a significant impact on product performance and variability, glycosylation is a critical quality attribute (CQA) influencing product safety and efficacy. Protein glycosylation can affect isolation and purification steps (process consistency), pharmacokinetics (half-life) properties and in vitro stability (product shelf-life). Sialic acid content is especially important as it can impact the stability and clearance of a protein.
ForteBio’s Sialic Acid (GlyS) Kit provides a rapid and convenient method for relative screening of terminal sialic acid content in crude or purified samples. Sialic acid data can be combined with titer data using Octet Data Analysis HT software version 11.1 or higher to funnel through samples that are high producers and have desirable sialic acid content.
Conference Hall L, Hall 7, Pavillion 2 Europe/Moscow

Session B – Technologies and equipment for pharmaceutical production

High-throughput glycan screening of crude and purified samples

Glycosylation is considered among the most important post-translational modifications when developing new biologics. Having a significant impact on product performance and variability, glycosylation is a critical quality attribute (CQA) influencing product safety and efficacy. Protein glycosylation can affect isolation and purification steps (process consistency), pharmacokinetics (half-life) properties and in vitro stability (product shelf-life). Sialic acid content is especially important as it can impact the stability and clearance of a protein.
ForteBio’s Sialic Acid (GlyS) Kit provides a rapid and convenient method for relative screening of terminal sialic acid content in crude or purified samples. Sialic acid data can be combined with titer data using Octet Data Analysis HT software version 11.1 or higher to funnel through samples that are high producers and have desirable sialic acid content.

Speakers

Sergey Irkhin
Senior manager of promotion department , Dia-M LLC

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20 November

16:50 - 17:00

Discussion & closing remarks

Day 3

Seminars - November, 21

21 November

10:30 - 11:30

Prezentation Zone B, Hall 8, Pavillion 2


Add to calendar 11/21/2019 10:30 11/21/2019 11:30 Seminar by Alfa Lab: New criterias of protective clothing selection Prezentation Zone B, Hall 8, Pavillion 2 Europe/Moscow

Seminars

Seminar by Alfa Lab: New criterias of protective clothing selection

21 November

11:00 - 12:00

Presentation Zone A, Hall 7, Pavillion 2


Add to calendar 11/21/2019 11:00 11/21/2019 12:00 Seminar by Merck: BioContinuum. Merck Biopharm Continuous Processing Platform Presentation Zone A, Hall 7, Pavillion 2 Europe/Moscow

Seminars

Seminar by Merck: BioContinuum. Merck Biopharm Continuous Processing Platform

21 November

11:40 - 12:40

Prezentation Zone B, Hall 8, Pavillion 2


Add to calendar 11/21/2019 11:40 11/21/2019 12:40 Seminar by Alfa Lab: Advanced cleaning solutions with deconex® for the biotech production Prezentation Zone B, Hall 8, Pavillion 2 Europe/Moscow

Seminars

Seminar by Alfa Lab: Advanced cleaning solutions with deconex® for the biotech production

21 November

12:10 - 13:10

Presentation Zone A, Hall 7, Pavillion 2


Add to calendar 11/21/2019 12:10 11/21/2019 13:10 Seminar by HVD: Third generation QCM biosensors, miniaturized immunoassays & High-throughput screening for R&D and Analytics Presentation Zone A, Hall 7, Pavillion 2 Europe/Moscow

Seminars

Seminar by HVD: Third generation QCM biosensors, miniaturized immunoassays & High-throughput screening for R&D and Analytics

21 November

12:50 - 13:50

Prezentation Zone B, Hall 8, Pavillion 2


Add to calendar 11/21/2019 12:50 11/21/2019 13:50 Seminar by NPK "Relsib": Devices and systems of NPK "Relsib" for monitoring the conditions of storage and transportation of medicines Prezentation Zone B, Hall 8, Pavillion 2 Europe/Moscow

Seminars

Seminar by NPK "Relsib": Devices and systems of NPK "Relsib" for monitoring the conditions of storage and transportation of medicines

21 November

13:20 - 14:20

Presentation Zone A, Hall 7, Pavillion 2


Add to calendar 11/21/2019 13:20 11/21/2019 14:20 Seminar by Antares Vision: Product inspection & traceability: how interconnection will speed up a new digital standard Presentation Zone A, Hall 7, Pavillion 2 Europe/Moscow

Seminars

Seminar by Antares Vision: Product inspection & traceability: how interconnection will speed up a new digital standard

21 November

14:00 - 15:00

Prezentation Zone B, Hall 8, Pavillion 2


Add to calendar 11/21/2019 14:00 11/21/2019 15:00 Seminar by Fizlabpribor: Practical experience in introducing innovative domestic developments in the pharmaceutical production of biotechnological substances Prezentation Zone B, Hall 8, Pavillion 2 Europe/Moscow

Seminars

Seminar by Fizlabpribor: Practical experience in introducing innovative domestic developments in the pharmaceutical production of biotechnological substances

21 November

15:10 - 16:10

Prezentation Zone B, Hall 8, Pavillion 2


Add to calendar 11/21/2019 15:10 11/21/2019 16:10 Track & Trace. Future of supply chain management: book presentation by Ravil Gimadiev, Original Group, CEO Prezentation Zone B, Hall 8, Pavillion 2 Europe/Moscow

Seminars

Track & Trace. Future of supply chain management: book presentation by Ravil Gimadiev, Original Group, CEO

21 November

16:20 - 17:20

Prezentation Zone B, Hall 8, Pavillion 2


Add to calendar 11/21/2019 16:20 11/21/2019 17:20 Seminar by Boccard: Plasma Fractionation: best practices for successful technology transfers Prezentation Zone B, Hall 8, Pavillion 2 Europe/Moscow

Seminars

Seminar by Boccard: Plasma Fractionation: best practices for successful technology transfers

Pharmtechprom forum - November, 21

Date: November, 20-21 
Place: Conference Hall L, Hall 7, Pavillion 2
Participation: free, electronic ticket based
Language: Russian

Download the forum programme>>

21 November

10:00 - 13:30

Session C – Packaging equipment and materials. Moderator: Vladimir Stolypin, Erecton (Russia), Production Director, Ph.D.

21 November

10:00 - 10:25

Registration of participants

21 November

10:30 - 11:00

Conference Hall L, Hall 7, Pavillion 2


Add to calendar 11/21/2019 10:30 11/21/2019 11:00 New trends in primary packaging. Child safety 1.  Facts - Medicine mis-taken by children under 5 year old;
2. Regulations and mandatory requirements on Child Safety packaging-Russia, EU, USA and China;
3. Developing status and trends on Child Safety packaging-Russia, EU, USA and China.
Conference Hall L, Hall 7, Pavillion 2 Europe/Moscow

Session C – Packaging equipment and materials

New trends in primary packaging. Child safety

1.  Facts - Medicine mis-taken by children under 5 year old;
2. Regulations and mandatory requirements on Child Safety packaging-Russia, EU, USA and China;
3. Developing status and trends on Child Safety packaging-Russia, EU, USA and China.

Speakers

Janny Hsing
General Manager, Overseas Division , Bona Pharma Packaging

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21 November

11:05 - 11:35

Conference Hall L, Hall 7, Pavillion 2


Add to calendar 11/21/2019 11:05 11/21/2019 11:35 New solutions for a vital process: Implementing aseptic filling with Ready-to-Use molded glass vials
The introduction of Sterinity by SGD Pharma (Paris, France), a global leader of molded glass packaging, makes the manufacture of RTU molded glass vials commercially accessible for the first time. Powered by the well-established EZ Fill® platform from Ompi (Padua, Italy) this new product extends the commercial and practical benefits of RTU to a widest range of applications. 
The Sterinity offer provides an ‘off-the-shelf’ solution for aseptic filling, producing RTU molded glass vials suitably packaged for streamlined, final ‘fill and finish’ processing in a range of proprietary filling technology.  Sterinity is leveraging the advantages of Ompi EZ-fill® secondary packaging, that has been already tested and adopted in a wide range of fill-finish equipment platforms.  
Vials are produced and 100% inspected in a clean room environment at the SGD Pharma plant, then washed with WFI, depyrogenized, packed and sterilized by ethylene oxide. Packed and sealed, RTU glass vials can be stored, with 5 years shelf life, and/or transported, ready for use as required.
The Sterinity offer uses molded glass vials made from Type I glass of exemplary quality. A steadily expanding portfolio of products in a range of sizes will be commercialized over the next one to two years, focusing on two core designs: a premium quality ISO design and an optimized EasyLyo® product. Both types of vial are currently available for use in tray format; nest and tub configurations are currently in development.
Sterinity boasts a diverse glass vial portfolio that meets all industry standards and customer requirements. As the need for flexible filling increases, companies will be seeking a cost-effective quality solution to streamline production and increase the speed of changeover. As the first commercial solution for RTU molded glass, SGD Pharma’s Sterinity platform is a viable answer to this pressing issue. 
Conference Hall L, Hall 7, Pavillion 2 Europe/Moscow

Session C – Packaging equipment and materials

New solutions for a vital process: Implementing aseptic filling with Ready-to-Use molded glass vials

The introduction of Sterinity by SGD Pharma (Paris, France), a global leader of molded glass packaging, makes the manufacture of RTU molded glass vials commercially accessible for the first time. Powered by the well-established EZ Fill® platform from Ompi (Padua, Italy) this new product extends the commercial and practical benefits of RTU to a widest range of applications. 
The Sterinity offer provides an ‘off-the-shelf’ solution for aseptic filling, producing RTU molded glass vials suitably packaged for streamlined, final ‘fill and finish’ processing in a range of proprietary filling technology.  Sterinity is leveraging the advantages of Ompi EZ-fill® secondary packaging, that has been already tested and adopted in a wide range of fill-finish equipment platforms.  
Vials are produced and 100% inspected in a clean room environment at the SGD Pharma plant, then washed with WFI, depyrogenized, packed and sterilized by ethylene oxide. Packed and sealed, RTU glass vials can be stored, with 5 years shelf life, and/or transported, ready for use as required.
The Sterinity offer uses molded glass vials made from Type I glass of exemplary quality. A steadily expanding portfolio of products in a range of sizes will be commercialized over the next one to two years, focusing on two core designs: a premium quality ISO design and an optimized EasyLyo® product. Both types of vial are currently available for use in tray format; nest and tub configurations are currently in development.
Sterinity boasts a diverse glass vial portfolio that meets all industry standards and customer requirements. As the need for flexible filling increases, companies will be seeking a cost-effective quality solution to streamline production and increase the speed of changeover. As the first commercial solution for RTU molded glass, SGD Pharma’s Sterinity platform is a viable answer to this pressing issue. 

Speakers

Rasa Krivickiene
Head of Sales for Eastern Market , UAB "LS Consult" Powered by SGD Pharma

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21 November

11:40 - 12:10

Conference Hall L, Hall 7, Pavillion 2


Add to calendar 11/21/2019 11:40 11/21/2019 12:10 Packing trends for Biologic Drugs
In the last years we see a clear separation in the market, the blockbuster strategy of medication is added by new drugs, often known as BioTech products.  This products are still pre-filled into syringes and vials till application. But on one hand we see shrinking batch sizes, due to orphan medication, due to a reduced number of potential patients. Higher concentrations of products, new complex molecules and new applications creates a demand on sophisticated new packaging material.
Which are options we can offer to the market? Polymer prefilled syringes are one option, but existing systems made of glass have been improved to fulfill the needs too. Nested vials are a new offering on the market. Potential risk asks for a minimized particle level, reduced or completely eliminated siliconization, metal free forming to avoid tungsten residuals, strengthen glass accepting pH attacks and mechanical impact, an extreme low extractable and leachable profile and very precise tolerances to work best with drug and device are addressed in this presentation.
We will show existing and future solutions for an demanding market on primary packaging solutions. Discussing about technical and logistic options to serve the needs of today and tomorrow’s medication. The best packaging material options for your individual product will be demonstrated.
Conference Hall L, Hall 7, Pavillion 2 Europe/Moscow

Session C – Packaging equipment and materials

Packing trends for Biologic Drugs

In the last years we see a clear separation in the market, the blockbuster strategy of medication is added by new drugs, often known as BioTech products.  This products are still pre-filled into syringes and vials till application. But on one hand we see shrinking batch sizes, due to orphan medication, due to a reduced number of potential patients. Higher concentrations of products, new complex molecules and new applications creates a demand on sophisticated new packaging material.
Which are options we can offer to the market? Polymer prefilled syringes are one option, but existing systems made of glass have been improved to fulfill the needs too. Nested vials are a new offering on the market. Potential risk asks for a minimized particle level, reduced or completely eliminated siliconization, metal free forming to avoid tungsten residuals, strengthen glass accepting pH attacks and mechanical impact, an extreme low extractable and leachable profile and very precise tolerances to work best with drug and device are addressed in this presentation.
We will show existing and future solutions for an demanding market on primary packaging solutions. Discussing about technical and logistic options to serve the needs of today and tomorrow’s medication. The best packaging material options for your individual product will be demonstrated.

Speakers

Dr. Wenzel Novak
Global Senior Director Business Development , Gerresheimer AG

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21 November

12:15 - 12:45

Presentation Zone A, Hall 7, Pavillion 2


Add to calendar 11/21/2019 12:15 11/21/2019 12:45 Ready-to-use packaging solutions to transform injectable drug manufacturing

1) Global RTU-standard with SCHOTT.

2) Key benefits of standardization of the iQ-Platform.

3) 3 products – all in one tub.

4) Accelerate drug development and market launch.

5) Flexibility in injection drug manufacturing with iQ™ Platform.

6) Perfect Fit components for iQ™ Platform.

7) Flexible fillings concept – tendency to increase.

8) Clean manufacturing process – No issues with glass breakage and particles with RTU containers.

9)  Enhance patience safety with iQ™ Platform.

Presentation Zone A, Hall 7, Pavillion 2 Europe/Moscow

Session C – Packaging equipment and materials

Ready-to-use packaging solutions to transform injectable drug manufacturing

1) Global RTU-standard with SCHOTT.

2) Key benefits of standardization of the iQ-Platform.

3) 3 products – all in one tub.

4) Accelerate drug development and market launch.

5) Flexibility in injection drug manufacturing with iQ™ Platform.

6) Perfect Fit components for iQ™ Platform.

7) Flexible fillings concept – tendency to increase.

8) Clean manufacturing process – No issues with glass breakage and particles with RTU containers.

9)  Enhance patience safety with iQ™ Platform.

Speakers

Larissa Ostroukh
Area Sales Manager, Russia & CIS , SCHOTT AG, Pharmaceutical Systems

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21 November

12:50 - 13:20

Conference Hall L, Hall 7, Pavillion 2


Add to calendar 11/21/2019 12:50 11/21/2019 13:20 Sympfiny®, an award-winning innovative oral delivery system for distribution of multiparticulate drug formulations
Sympfiny® is an innovative oral delivery system for dosing and dispensing dry powder, microsphere and multiparticulate drug formulations.
This breakthrough system enables caregivers to store, extract and deliver dry drugs with the same familiar technique used for liquid oral drugs.
The patent pending design allows controlled and precise dosage and ensures all the medication is dispensed directly to the patient’s mouth. The compact, portable container was designed to be used in a wide variety of settings and by a diverse set of users.
Designed with the entire supply chain in mind, the system fits common bottle sizes and can be pre-filled or filled at a pharmacy. The internal valve and bottle cap protects the drug through storage and use. The re-usable syringe comes in two sizes and has selectable dose settings.
Further in this presentation you will hear detailed discussion about:
 
  1. Versatile Bulk Container
• On site fill capability
• Humidity resistant
• Easy to customize
• Compatible with child-proof caps
  1. Novel Interlocking Design
• Simple to use
• Prevents accidental drug spills
• Seals against contaminants
  1. Intuitive Dispensing Platform
• Dispenses similarly to liquid oral syringe
• One handed operation
• Reusable and easy to clean
  1. User Friendly Dose Settings
• Multiple dose settings in a single platform
• Customizable by pharmacist or caregiver to meet the needs of the patient population
 
Conference Hall L, Hall 7, Pavillion 2 Europe/Moscow

Session C – Packaging equipment and materials

Sympfiny®, an award-winning innovative oral delivery system for distribution of multiparticulate drug formulations

Sympfiny® is an innovative oral delivery system for dosing and dispensing dry powder, microsphere and multiparticulate drug formulations.
This breakthrough system enables caregivers to store, extract and deliver dry drugs with the same familiar technique used for liquid oral drugs.
The patent pending design allows controlled and precise dosage and ensures all the medication is dispensed directly to the patient’s mouth. The compact, portable container was designed to be used in a wide variety of settings and by a diverse set of users.
Designed with the entire supply chain in mind, the system fits common bottle sizes and can be pre-filled or filled at a pharmacy. The internal valve and bottle cap protects the drug through storage and use. The re-usable syringe comes in two sizes and has selectable dose settings.
Further in this presentation you will hear detailed discussion about:
 
  1. Versatile Bulk Container
• On site fill capability
• Humidity resistant
• Easy to customize
• Compatible with child-proof caps
  1. Novel Interlocking Design
• Simple to use
• Prevents accidental drug spills
• Seals against contaminants
  1. Intuitive Dispensing Platform
• Dispenses similarly to liquid oral syringe
• One handed operation
• Reusable and easy to clean
  1. User Friendly Dose Settings
• Multiple dose settings in a single platform
• Customizable by pharmacist or caregiver to meet the needs of the patient population
 

Speakers

Tamas Öri
Regional Sales Manager Eastern Europe , Röchling Medical Neuhaus GmbH & Co. KG

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21 November

13:20 - 13:30

Discussion

21 November

14:00 - 17:00

Session D – Auxiliary processes in pharmaceutical production. Moderator: Oleg Spitsky, Biopharmprogect (Russia), Quality System Manager, GMP Expert

21 November

14:00 - 14:30

Conference Hall L, Hall 7, Pavillion 2


Add to calendar 11/21/2019 14:00 11/21/2019 14:30 Lifecycle Management of design and implementation of a new pharmaceutical production
Construction of new production units (sites) in the pharmaceutical industry depends on a number of factors, such as introduction of new technologies or products, modernization or replacement of existing equipment, expansion of production capacities, transfer of production and packaging to economically more profitable places. The purpose of such construction is, of course, the satisfaction of all legislative requirements for regulating the circulation of medicines, as well as achieving an effective competitive advantage in the market. Also, these projects will meet the strategic goals of pharmaceutical manufacturers with requirements for registration of medicines, requirements of good practices (GLP, GCP, GMP, GDP), good engineering practice (GEP), rules for managing construction projects, requirements for commissioning and approaches for drug marketing in selected markets.
In the «Project Management for the Pharmaceutical Industry» guide, ISPE gives recommendations on how to implement such projects throughout their entire life cycle. During the project life cycle, there are three phases that are divided into six stages:
 
  1. Project initiation          -      2. Planning            -          3. Project Delivery
 
Feasibility  -  Conceptual  -  Project Delivery  -  Design  -  Implementation  -  Close-out                                              
                    Development          Planning               
Conference Hall L, Hall 7, Pavillion 2 Europe/Moscow

Session D – Auxiliary processes in pharmaceutical production

Lifecycle Management of design and implementation of a new pharmaceutical production

Construction of new production units (sites) in the pharmaceutical industry depends on a number of factors, such as introduction of new technologies or products, modernization or replacement of existing equipment, expansion of production capacities, transfer of production and packaging to economically more profitable places. The purpose of such construction is, of course, the satisfaction of all legislative requirements for regulating the circulation of medicines, as well as achieving an effective competitive advantage in the market. Also, these projects will meet the strategic goals of pharmaceutical manufacturers with requirements for registration of medicines, requirements of good practices (GLP, GCP, GMP, GDP), good engineering practice (GEP), rules for managing construction projects, requirements for commissioning and approaches for drug marketing in selected markets.
In the «Project Management for the Pharmaceutical Industry» guide, ISPE gives recommendations on how to implement such projects throughout their entire life cycle. During the project life cycle, there are three phases that are divided into six stages:
 
  1. Project initiation          -      2. Planning            -          3. Project Delivery
 
Feasibility  -  Conceptual  -  Project Delivery  -  Design  -  Implementation  -  Close-out                                              
                    Development          Planning               

Speakers

Zdenek Pavelek
Quality Director , FAVEA

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21 November

14:35 - 15:05

Conference Hall L, Hall 7, Pavillion 2


Add to calendar 11/21/2019 14:35 11/21/2019 15:05 Global revision of EU GMP and ISO PPE. What will we consider when choosing cleanroom garments and gloves

The global trend of transition from reusable garment to disposable ones: its advantages and great necessity. The most common misconception in the process of choosing cleanrooms garments. The parameters are usually not taken into account when comparing costs of cycles of disposable and reusable garments. The way the European GMP project specifies requirements for garment (detailed cases).

Changes in the European legislation concerning personal protective equipment and GOST, planned to have been adopted in the Russian Federation in 2020 (ISO 374-2016). Process of sorting out a new labeling of personal protective equipment.

As a bonus you’ll get a guide "How to choose very fast and - what is more important – accurate an optimal hands chemicals protection for your production with a help of a unique tool - Chemical Guardian"

Conference Hall L, Hall 7, Pavillion 2 Europe/Moscow

Session D – Auxiliary processes in pharmaceutical production

Global revision of EU GMP and ISO PPE. What will we consider when choosing cleanroom garments and gloves

The global trend of transition from reusable garment to disposable ones: its advantages and great necessity. The most common misconception in the process of choosing cleanrooms garments. The parameters are usually not taken into account when comparing costs of cycles of disposable and reusable garments. The way the European GMP project specifies requirements for garment (detailed cases).

Changes in the European legislation concerning personal protective equipment and GOST, planned to have been adopted in the Russian Federation in 2020 (ISO 374-2016). Process of sorting out a new labeling of personal protective equipment.

As a bonus you’ll get a guide "How to choose very fast and - what is more important – accurate an optimal hands chemicals protection for your production with a help of a unique tool - Chemical Guardian"

Speakers

Vyacheslav Ryadinsky
SC "Chemical, PU, LSE" , Ansell

Explore

21 November

15:10 - 15:40

Conference Hall L, Hall 7, Pavillion 2


Add to calendar 11/21/2019 15:10 11/21/2019 15:40 Review of regulatory requirements for cold chain ambient conditions monitoring. Hardware and software solutions 1.            Comparison of applicable legal requirements for transportation and storage temperature of sensitive pharmaceuticals at each step of the cold chain
2.            Upcoming  changes in regulatory and market requirements for temperature monitoring
3.            Recent  changes in the methodological approaches
4.            Review of existing and perspective technical/software solutions for temperature monitoring
 
Conference Hall L, Hall 7, Pavillion 2 Europe/Moscow

Session D – Auxiliary processes in pharmaceutical production

Review of regulatory requirements for cold chain ambient conditions monitoring. Hardware and software solutions

1.            Comparison of applicable legal requirements for transportation and storage temperature of sensitive pharmaceuticals at each step of the cold chain
2.            Upcoming  changes in regulatory and market requirements for temperature monitoring
3.            Recent  changes in the methodological approaches
4.            Review of existing and perspective technical/software solutions for temperature monitoring
 

Speakers

Bulat Salikhyanov
Key account manager Pharma , Testo Rus

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21 November

15:45 - 16:15

Conference Hall L, Hall 7, Pavillion 2


Add to calendar 11/21/2019 15:45 11/21/2019 16:15 21 CFR part 11 compliant automation of quality control to reduce costs in pharmaceutical A recent report by Pharmaceutical Online suggests that circa 79% of 483 warning letters issued by the FDA to the biopharmaceutical industry sited deficiencies in their data integrity.
Despite guidance from the FDA, cleanroom environmental monitoring  and quality control (water for injection) remains an intensely manual process, with many opportunities for human error to create gaps and errors in the data.
In their 21CFR part 11 guidance, the FDA have given recommendations on what good data integrity looks like and this presentation explains their advice in the context of current cleanroom environmental practices and quality control (water for injection) and shows how the FDA guidance can be applied to improve data integrity.
Conference Hall L, Hall 7, Pavillion 2 Europe/Moscow

Session D – Auxiliary processes in pharmaceutical production

21 CFR part 11 compliant automation of quality control to reduce costs in pharmaceutical

A recent report by Pharmaceutical Online suggests that circa 79% of 483 warning letters issued by the FDA to the biopharmaceutical industry sited deficiencies in their data integrity.
Despite guidance from the FDA, cleanroom environmental monitoring  and quality control (water for injection) remains an intensely manual process, with many opportunities for human error to create gaps and errors in the data.
In their 21CFR part 11 guidance, the FDA have given recommendations on what good data integrity looks like and this presentation explains their advice in the context of current cleanroom environmental practices and quality control (water for injection) and shows how the FDA guidance can be applied to improve data integrity.

Speakers

Ekaterina Shakh
Research and Industry Group Manager Russia, other CIS, Israel , Beckman Coulter Life Sciences

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21 November

16:20 - 16:50

Conference Hall L, Hall 7, Pavillion 2


Add to calendar 11/21/2019 16:20 11/21/2019 16:50 Solutions from Advanced Microdevices (MDI) for pharmaceutical industries. Single use systems for biotechnology. Customized systems
Introduction of single use technologies  in the production process is the recent trend in biopharmaceutical field.
 
Production based on single use materials allows both large scale manufacturing of high-tech products in a short time and full compliance with quality standards. Unlike traditional solutions, single use technologies help to achieve significant savings of resources and time. As a result, companies, which use these technologies, highly improve their financial performance.
 
Founded in 1976, Advanced Microdevices (MDI) started its business with one single product. Nowadays MDI produces more than 2 million items, including products for laboratory and industrial scale membrane filtration, components for diagnostic tests and consumables for biotechnology. MDI exports its products to more than 50 countries all around the world.
 
The company produces a wide range of sterile disposable systems for various critical biopharmaceuticals and pharmaceuticals protocols. This includes simple systems for storage, transportation, preparation of solution, thawing and freezing, aseptic transmission; bags with straps and holders for bioreactors, intermediate storage and transportation; complex multicomponent assemblies with built-in filters for unique projects.
Conference Hall L, Hall 7, Pavillion 2 Europe/Moscow

Session D – Auxiliary processes in pharmaceutical production

Solutions from Advanced Microdevices (MDI) for pharmaceutical industries. Single use systems for biotechnology. Customized systems

Introduction of single use technologies  in the production process is the recent trend in biopharmaceutical field.
 
Production based on single use materials allows both large scale manufacturing of high-tech products in a short time and full compliance with quality standards. Unlike traditional solutions, single use technologies help to achieve significant savings of resources and time. As a result, companies, which use these technologies, highly improve their financial performance.
 
Founded in 1976, Advanced Microdevices (MDI) started its business with one single product. Nowadays MDI produces more than 2 million items, including products for laboratory and industrial scale membrane filtration, components for diagnostic tests and consumables for biotechnology. MDI exports its products to more than 50 countries all around the world.
 
The company produces a wide range of sterile disposable systems for various critical biopharmaceuticals and pharmaceuticals protocols. This includes simple systems for storage, transportation, preparation of solution, thawing and freezing, aseptic transmission; bags with straps and holders for bioreactors, intermediate storage and transportation; complex multicomponent assemblies with built-in filters for unique projects.

Speakers

Andrey Zavarzin
CEO , Greenvan LLC

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21 November

16:50 - 17:00

Discussion & closing remarks

Day 4

Project results

22 November

11:00 - 12:00

Presentation Zone A, Hall 7, Pavillion 2


Add to calendar 11/22/2019 11:00 11/22/2019 12:00 Pharmtech Tutor 2019: results Presentation Zone A, Hall 7, Pavillion 2 Europe/Moscow

Project results

Pharmtech Tutor 2019: results