Course overview
The pharmaceutical markets in Russia, the Eurasian Union and the CIS are of growing commercial importance and companies looking to take advantage of the opportunities available need to be fully up to date with the evolving regulatory landscape for human pharmaceuticals, including the potential for market access offered by the latest legislation.
This interactive course will guide you through national procedures as well as exploring the implications of and updates on the Eurasian Union regulation.
The focus of the programme is to offer practical advice in developing your regulatory strategy for product approval in these countries and you will get the full benefit of our trainer’s experience and expertise in the region.
CPD Hours: 12
Course Content
- Day 1
- CIS - regional regulatory overview
- Common regional requirements in CIS
- Eurasian economic area
- Eurasian Regulations for Medicines
- Day 2
- Registration of Medicine in Russia
- National Regulatory Procedures in Russia
- Registration in other EAEU countries
- Registration in other CIS countries
- Workshop - CIS Regional Regulatory Strategy
Speakers
Anna Harrington-Morozova
Anna Harrington-Morozova is a regulatory, drug development and external relations professional with over 20 years’ experience gained working in a Regulatory Authority, academia and industry. Anna graduated in Russia as a pharmacist. After working in the Russian Ministry of Health and the Clinical Pharmacology Department of Moscow Medical University, she 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 a a Scientific and Reguatory director at Regem Consulting Ltd - a consultancy which focuses on drug development, global regulatory advice, professional trainings and flexible resourcing solutions for the pharmaceutical, biotech and medical device industries in emerging markets.
