Biotherapeutic medicines are an important and integral component of modern medicinal advancement, and represent the new generation of highly-specific and targeted treatments. Because these products require a harmonized, scientific and reasonable regulatory approach, the question of importance of state regulation has risen in the Russian Federation.
This high-level conference will convene experts and regulators from different regions and will serve as a platform to share the experiences and best practices on the development and implementation of biologic and biosimilar regulations. The sessions will also allow discussions and debates on key topics such as regulatory pathways for biotherapeutic medicines and biosimilars; quality aspects of development; comparability and similarity exercises; preclinical and clinical data; immunogenicity; pharmacovigilance and safety tracking; and interchangeability. Speakers will include representatives of the World Health Organization; national regulatory authorities; independent experts; and industry.
Format: 2 day workshop which joins representatives of national regulatory authorities and biopharmaceutical industry experts from EU, North America, Commonwealth of Independent States (CIS) and other regions. The event will feature different sessions dealing with specific topics. Each session will include presentations from regulatory authorities and experts and an interactive Q&A and discussion with the public. With expert participation of:
• World Health Organization
• National Regulatory Authorities
• Russian Academy of Medical Science
• Independent Experts
• Biopharmaceutical industry.

The meeting is free of charge.
If you have any questions please contact the IFPMA Biotherapeutics Secretariat at Biothera@ifpma.org.