The pharmaceutical markets within Russia,the Eurasian union,and the Commonwealth of Autonomous States (CIS) are gaining meaningful commercial traction. Companies aiming to capitalize on these opportunities must stay informed about the evolving regulatory landscape governing human pharmaceuticals. This includes understanding the potential market access facilitated by recent legislation.

Navigating the Regulatory maze: A Training Course Overview

A specialized training course focuses on pharmaceutical regulatory affairs in Russia and the Eurasian Union. This interactive program is designed to guide participants through national procedures and explore the implications of the Eurasian Union regulation. The course emphasizes practical advice for developing regulatory strategies aimed at securing product approval within these regions.

Key Benefits of Participation

• Understand the competitive dynamics of the expanding markets in the CIS region.
• Discover essential details regarding the latest regulations and registration processes within the Eurasian Customs Union.
• Discuss national requirements and guidelines for drug approval in key CIS markets, including Russia, Kazakhstan, Belarus, Ukraine, and Azerbaijan.
• Develop a CIS regional submission plan that aligns with your broader global regulatory strategy.
• Gain practical insights from an industry expert with direct experience in the CIS region.

Why Attend? Key Takeaways

Participation in this program offers several critical advantages:

• Gain a extensive understanding of the CIS pharmaceutical market.
• Ensure a thorough grasp of the implications of the latest regulations affecting business operations within the Eurasian Economic Union (EAEU).
• Clarify document requirements and timelines associated with national procedures and EAEU registration processes.
• Stay updated on national regulations in Russia, Belarus, Kazakhstan, Ukraine, and other CIS countries.

Certification Details

• CPD: 12 hours for professional records.
• Certificate of completion.

Who Should Attend?

This seminar is notably beneficial for individuals who need to understand successful marketing authorization applications and regulatory compliance in the CIS region. It serves as both an introductory and refresher course.

Course Highlights: A two-Day Overview

Day 1

CIS – Regional Regulatory Overview

• CIS and Russia Market Overview
• Market protection policies
• CIS and Russia in regional and international Regulatory Harmonisation

Common Regional Requirements in CIS

• Administrative data, translations, normative documents, samples, labelling, etc.

Eurasian Economic Area

• Countries current members of EAEU and EAEU official bodies
• History of EUAE, scope of products, available experience
• Terms of transition period for medicines

Eurasian Regulations for Medicines

• Overview of EAEU regulatory framework
• Registration Procedures and Request Process
• EAEU submission documents and data requirements
• GMP inspections
• PhV requirements

Day 2

Registration of Medicine in Russia

• Regulatory authorities in Russia
• Key regulations governing the registration process
• Clinical trials

National Regulatory Procedures in Russia

• Application dossier and data requirements
• Post approval life cycle maintenance applications
• Safety reporting and market surveillance
• Price and reimbursement
• Patent data protection

Registration in other EAEU countries

• Kazakhstan, Belarus, Armenia, Kirgizstan

Registration in other CIS countries

• EU sphere of influence: Ukraine, Moldova, Georgia
• National procedures: Azerbaijan, Uzbekistan, Tajikistan, Turkmenistan

Workshop – CIS Regional Regulatory Strategy

Expert Insight

The course features insights from experienced professionals like Anna Harrington-Morozova, Scientific and regulatory Director at Regem Consulting ltd.

Anna Harrington-Morozova is a regulatory, drug growth and external relations professional with over 20 years’ experience gained in regulatory authority, academia, clinical and industry environment. Anna graduated in Russia as a pharmacist. After working in the Russian ministry of Health and the Clinical Pharmacology Department of Moscow Medical University Anna held regulatory and external relation positions in the pharmaceutical industry and CROs in russia and the UK, including senior regulatory affairs posts in GSK, EISAI, ICON and PRA. Anna currently acts as a Scientific and Regulatory Director at Regem Consulting Ltd – a regulatory and drug development consultancy with a focus on global regulatory and drug development strategies,advocacy and registrations in emerging markets.

Anna Harrington-Morozova, Scientific and Regulatory Director, Regem Consulting Ltd