January 30, 2013

How to Ensure Pharmacovigilance Practices are Compliant with Global Safety Requirements: Challenges in Asia-Pacific

How to Ensure Pharmacovigilance Practices are Compliant with Global Safety Requirements: Challenges in Asia-Pacific

National Regulators enact various Pharmacovigilance (PV) regulations in order to ensure that medicines and medical devices are acceptably safe. These regulations and guidelines from the Council for International Organizations of Medical Sciences (CIOMS) and the International Conference on Harmonisation (ICH) guide how pharmaceutical companies manage day to day PV activities.

Although PV activities such as handling Individual Case Safety Reports (ICSRs), writing Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs) are standard processes managed by pharmaceutical companies, the way such activities are regulated by various Regulators is not always harmonized. Requirements and timelines can vary greatly amongst Regulators and are not always consistent with International Standards. As a result pharmaceutical companies need to ensure they comply with the various requirements and timelines from international Regulators.

This webinar will focus on ensuring compliance with international and local country specific PV Requirements from an Asia-Pacific perspective.

CEOs, Directors, VP, Heads and Team Leaders involved with

• Legislation and Policy Advice
• Biosimilar Strategists
• Business Development – EU, USA, and Emerging Markets
• Manufacturing
• Drug Development
• Bioequivalence
• Drug and Safety Assessment
• Market Strategy
• Regulatory Affairs
• APIs
• Intellectual Property
• Pricing Lead
• Project Lead

Michal Borawski, International Pharmacovigilance Officer for the Asia-Pacific Region
Affairs, Sanofi Pasteur

Mr. Borawski received his Doctorate from The Ernest Mario School of Pharmacy at Rutgers University. He completed a post-doctoral fellowship in Benefit Risk Management at Johnson & Johnson before joining the Global Pharmacovigilance Department at sanofi pasteur.

Mr. Borawski has been with sanofi pasteur for 5 years. He has been located in Singapore the last 3 years serving as the International Pharmacovigilance Officer for the Asia Pacific Region.