Course overview
This course provides a comprehensive overview of medical device regulatory affairs in Russia and the Eurasian Union. This interactive course will cover the regulatory requirements within these regions, focusing on practical aspects to assist in developing your regulatory strategy for product approval. The presentations will also give practical hints on the regulatory and registration process where possible.
CPD Hours: 12
Course Content
- Day 1
- Russia and CIS - Regional Regulatory Overview
- Eurasian Regulations for Medical Devices
- Registration of MDs in Russia
- Day 2
- Registration of MDs in Russia (continued)
- Common regional requirements in CIS
- Registration of MDs 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.
