The All-Russian GMP Conference has been held since 2016 and annually collects information about international and international research in the field of the pharmaceutical industry, government authorities, information technology and pharmaceutical industry specialists, representatives of professional associations and communities, specialists in the field of quality system management and proper manufacturing practices (GMP).
Draft program of the VIII All-Russian GMP Conference with international participation
GMP: Good Quality in the current context
Main hall
Plenary session
Best Approaches to Regulation of Medicines in a Multipolar World
Part 1
Questions and topics for discussion:
- Capability of the Russian regulatory system to respond quickly to challenges while sustaining the high quality of medicines
- Global experience of pharmaceutical industry development
- Reducing the dependence on imports and building up the country’s own export potential
- Interaction of regulatory authorities in the current environment. Platforms for international cooperation
- International professional industry associations as a tool for advancing GMP guidelines. Global Association of Pharmaceutical Inspectorates
- Models of national regulatory authorities. Organization of interaction in the division of functions among regulatory authorities. Russia’s and different countries’ experience
- Mutual recognition. International experience
Main hall
Plenary session
Best Approaches to Regulation of Medicines in a Multipolar World
Part 2
Questions and topics for discussion:
- EAEU’s Strategy-2025: What is it and why? Results of the first years of the operation of the common pharmaceutical market and medicine registration procedure according to the EAEU guidelines
- Provisional procedure established for 2020-2023 by the national legislation of the EAEU member states for the circulation of medicines in terms of registration of medicines
- Inspections of pharmaceutical manufacturers as per the EAEU guidelines. Establishing uniform approaches
- Challenges Russian pharmaceutical enterprises face while entering the global markets
- Mutual recognition. International experience
Session partner: Binnopharm Group
Main hall
Panel discussion
Systemic View of Industry Education as a Factor in Outstripping Growth of the Pharmaceutical Industry
Topics for discussion:
- Common approaches to the modernization of industry education to ensure accelerated innovative development of the pharmaceutical industry
- Matching the competencies of specialists with the interests and needs of pharmaceutical enterprises
- Interaction of regulatory authorities on issues of industry education
- International experience in the pharmaceutical industry and expert opinions on the possibilities of applying advanced educational solutions in Russia and in the EAEU space
Main hall
Inter-Agency Cooperation for Enhancing the Pharmaceutical Market
Questions and topics for discussion:
- Issues of inter-agency cooperation
- Role of pharmaceutical inspections for compliance with GMP Rules in the regulation of medicines
- Specifics of releasing medicinal products
Main hall
Science-Based Approach to Pharmaceutical Manufacturing
Questions and topics for discussion:
- Goals, objectives and intermediate results of the activities by the Expert Council of the Eurasian Academy of Good Practices
- Approaches to microbiological monitoring of the production environment during the production of medicines. Requirements and practice in the application thereof.
- Scientific evidence of the toxicological assessment to confirm the possibility of manufacturing medicinal products on the same production line
- Toxicological evaluation of medicines for the purposes of compliance with the good manufacturing practice
- Draft Annex 1 – Requirements for Manufacture of Sterile Medicinal Products
- Qualified persons
- Requirements for the manufacture of ATMPs
Main hall
Panel session
Approaches to Licensing the Manufacture of Medicines
Questions and topics for discussion:
- Current requirements for licensing the production of medicines and periodic confirmation of compliance as an integral part thereof
- Licensing and GMP certification of quality control laboratories and other outsourced organizations performing separate stages. Approaches in different regions of the world
- Regulatory approaches to ensure compliance with licensing requirements by manufacturers of medicines (preventive measures and unscheduled control (supervisory) measures)
- WHO pre-qualification experience
- International experience in licensing the production of medicines
Session partner: WERTEKS
Main hall
Parallel Event
Specifics of Ensuring Compliance with the GMP Guidelines in the Production of Certain Types of Medicines
Russian and International Practice
Questions and topics for discussion:
- Innovations and state-of-the-art technologies in the pharmaceutical industry in the production of sterile medicines
- Single-Use Systems: Risks. Focused on while inspecting
- Specifics of ensuring the safety of high-tech medicines (ATMPs). What the developer needs to consider
- Control systems of biological products
- Practical challenges of implementing risk analysis of elemental impurities
- Extractable and leachable substances: requirements and approaches
- Shared manufacturing facilities for solid dosage forms. Experience in applying a risk-based approach
Session partner: Nacimbio
Small hall
Parallel Event
Master Class for university professors on VR Technologies for Teaching the Industrial Technology of Medicines, with the issuance of certificates
The participants of the master class will be able to get acquainted with the possibilities of the simulation training complex «Virtual Factory for Universities», developed by the Eurasian Academy of Good Practices in cooperation with the State Institute of Medicines and Good Practices. The innovative VR product is designed for students in pharmaceutical, biotechnological, and chemical fields to have an internship in industrial pharmacy. The complex contains unique licensed software and educational materials for teachers, including those who do not have experience working at a pharmaceutical company.
Session partner: SUN Pharma
Main hall
Parallel Event
Pharmaceutical Engineering. The initial stages of acceptance and qualification as part of the validation lifecycle of systems and equipment. A look from the perspective of the requirements of GMP Appendix No. 15 and industry experience
Questions and topics for discussion:
- Practical Application of the principles of the ISPE Baseline Guide Vol 5: Commissioning & Qualification 2nd Edition
- The relation of the various stages of qualification in the V-shaped model of the «life cycle» of validation
- URS as a «reference point» for validation activities
- Importance of the DQ stage for new and reconstructed systems; application of risk analysis at the DQ stage taking into account the provisions of the updated version of the ICH guideline Q9 (R1)
Main hall
Master Class. Part 1 (Theory)
Most Frequent Non-Conformities. Experience of Pharmaceutical Inspectorates of Various Countries
Questions and topics for discussion:
- Typical non-conformities of the pharmaceutical inspections of the member states of the Eurasian Economic Union
- Experience of other countries’ pharmaceutical inspectorates
Session partner: PRO.MED.CS Praha a. s.