The Pan-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 9th Pan-Russian GMP Conference with international engagement
GMP: Continuous Improvement in Pharmaceutical Industry
Registration and Coffee
Concert Hall
Plenary Session
Development Trends of Pharmaceutical Regulatory System
Panel 1
-
Tools for strengthening regulatory systems
-
Regulatory reliance: benefits and pitfalls. International experience
-
Isolation of regulatory systems: deterrence or decrease of dependency on external challenges
-
Should the regulatory system remain flexible? To what extent?
-
Regulatory system readiness to ensure access to medicinal products
-
Development of local production to ensure safety of medicinal products
-
Development strategy for production of novel drugs
Coffee and Networking Break
Concert Hall
Plenary Session
Development Trends of Pharmaceutical Regulatory System
Panel 2
-
•Regional unions — advantages and disadvantages for manufacturers of medicinal products
-
EAEU Common Market for Medicinal Products turned 10 years old: results and perspectives
-
Foreign pharmaceutical market access
-
Role of regulatory convergence between different countries in overcoming trade barriers
Lunch Break
In Parallel
Concert Hall
Panel Discussion
Pharmaceutical Industry Interactions: From Science to Patient
- Interagency interaction in regulation of medicinal products
- Communication between the regulator, science and industry
Session partner: PRO.MED.CS Praha a. s.
In Parallel
Conference Hall 2
Interactive educational intensive class
Current aspects of conducting GMP self-inspection at pharmaceutical companies
-
APS for aseptic process validation
-
Elimination of system deficiencies caused by lack of time synchronization in production
-
Data integrity management for laboratory equipment
-
Equipment management process audit as a tool for identification of system errors in a production laboratory
-
System errors when handling validation and qualification
Session partner: Nacimbio
Coffee and Networking Break
Concert Hall
Master Class
BUSINESS GAME: Qualified persons
Evening Reception and Informal Networking
by invitation
Registration and Coffee
Conference Room
Panel Discussion
EAEU Common Market for Medicinal Products turned 10 years old: results and perspectives
- Harmonization of national legislation on pharmaceutical inspections with the EAEU laws
- Initiation of inspection within the framework of marketing authorization procedure
Session partner: Promomed
In Parallel
Conference Hall 2
Panel Session
Advisory Board. Coverage of Activities of Working Groups
-
Part IV – GMP Requirements for Advance Therapy Medicinal Products (ATMPs)
-
Annex 1 Production of Sterile Products. Legal Aspect: Contamination Control Strategy at the Enterprise
-
Draft Guidance on Environmental Monitoring in Production Areas
-
Scientific toxicological evaluation data to confirm the feasibility of manufacture of different medicinal products in shared facilities
-
Qualified persons. The EAEU Association of Qualified Persons
-
Current projects of the Working Group Pharmaceutical Engineering
In Parallel
Concert Hall
Panel Session
Manufacture of biological medicinal products
- Advanced Therapy Medicinal Products (ATMPs) and Biomedical Cellular Products (BCPs); expert and manufacturer opinions
- Experience in development and manufacture of products derived from human blood
Session partner: PHARMSTANDARD
Coffee and Networking Break
Concert Hall
Panel Session
Manufacturing Authorization: Control in Manufacturing, Expectations of a Regulatory Authority
-
Manufacturing authorization — from preparing documents to obtaining a manufacturing authorization/ GMP certificate
-
Passing the periodic assessment of compliance with the manufacturing authorization requirements; initial results
-
Experience with passing the periodic assessment of compliance with the manufacturing authorization requirements (pharmaceutical companies)
-
Audit of suppliers of raw materials, materials, and services
Lunch Break
In Parallel
Concert Hall
Panel Session
Approaches to the Development of Quality System
- Maturity Level of Pharmaceutical Quality System
- Maintaining corporate quality assurance: experience of local and foreign manufacturers.
-
Data integrity. Implementation in practice, regulatory expectations. Digitalization trends in pharmaceutical industry
In Parallel
Conference Hall 2
Panel Session
ISPE does not only mean pharmaceutical engineering
-
Concept Paper on the revision of EU GMP, Annex 11: prerequisites, expected changes and their interpretation
-
ICH Q19 (R1) – the new ICH Q9 (R1) Guideline on Quality Risk Management. Review of related ICH guidelines and training materials
-
Review of the new ISPE Baseline Guide Vol: Pharma 4.0 1st Edition. From Theory to Practice
-
Ongoing Process Verification as part of the requirements of Annex 15 to the EAEU GMP
Afternoon Break
Concert Hall
Master Class Practical cases (business game) on manufacturing authorization
Registration and Coffee
Concert Hall
Master Class. Part 1 (Theory).
- Most frequent non-conformities. Experiences of different foreign inspectorates.
Lunch Break
Concert Hall
Master Class. Part 2 (Hands on).
Interactive part: GMP Quiz