Panel discussion 12:20 – 13:50

Watch the program

12:20 - 13:50

Panel discussion

Interdisciplinary approach to regulating good practices (GxP)

Questions and topics for discussion:
● Regulatory pillars of effective regulation of drug lifecycle in Russia and EAEU: the role of good practices (GxP)
● Challenges of implementing GxP, their possible reasons and ramifications
● Effective regulation of Good Laboratory Practice (GLP) as a guarantor of safety and efficacy of drugs for patients
● Model of effective regulation of GLP from the perspective of EAEU Good Pharmacy Practice. Harmonization with world practice.
● Clinical studies in Russia: interrelationship between GCP with other good practices
● Ensuring the safety and quality of pharmaceutical products during storage, distribution and transportation
● Relevant regulatory issues and quality assurance forf dietary supplements
● Ways of improving the regulation of drug lifecycle from the good practices perspective: experience, analysis and suggestions.


Session partner company - Abbott

Moderator

Roman Drai

Roman Drai

Director of R&D center, Geropharm

Lilia Titova

Lilia Titova

Executive Director Union of Professional Pharmaceutical Organizations (SPFO)

Participants

Ekaterina Nikifirova

Elena Denisova

Deputy Director of Department of Pharmaceutical and Medical Industry Development, Russian Ministry of Industry and Trade

Maysie Vallejos Campos

Head of Good Practices Section, Institute of Public Health (Chile)

Ekaterina Nikifirova

Ferenc Lukács

Inspectorate Head of National Institute of Pharmacy and Nutrition (OGYÉI), Hungary

Igor Shokhin

General Director, Center of Pharmaceutical Analytics

Ekaterina Nikifirova

Dmitry Ivkin

Head of Center of experimental pharmacology, Saint-Petersburg State Chemical Pharmaceutical Academy

Ekaterina Nikifirova

Elena Shipaeva

Head of Non-clinical Group of Non-clinical trials and clinical trials of Medical Department, R-Pharm

Arina Selezneva

Deputy Head of Section for Good Practices (GLP focus), State Institute of Drugs and. Good Practices

Ekaterina Nikifirova

Kazei Vasily

General Director, Exakte Labs LLC

Ekaterina Nikifirova

Daria Varvarina

Tymlat factory, Vladivostok

Elena Mukovina

Quality Director, Evalar

Ekaterina Nikifirova

Leandro Villanueva

General Director of the General Directorate of Medicines, Food and Health Products of Ministry of Public Health of the Dominican Republic

Ekaterina Nikifirova

Rubina Bose

Deputy Drugs Controller, Central Drugs Standard Control Organisation (India)

Ekaterina Nikifirova

Stephan Rönninger

Director for Quality and External Affairs, Amgen (Switzerland)

Ekaterina Nikifirova

Veronika Galyamova

Executive Director, Katren JSC

Ekaterina Nikifirova

Margarita Mustafina

Head of Project Management, TEVA

Ekaterina Nikifirova

Olga Spiridonova

GDP inspector of the Inspectorate Department, “SID & GP” of the Russian Ministry of Industry and Trade

Ekaterina Nikifirova

Andres Vinicio de la Torre Conrado

Director of Sanitary Registries, Mandatory Sanitary Notification and Authorizations, National Agency for Health Regulation, Control and Surveillance (Ecuador)

Vyacheslav Goryachkin

Head of Section for Good Practices, “SID & GP” of the Russian Ministry of Industry and Trade

Partners

Session content