Drug Safety and Pharmacovigilance Best Practices for Small to Medium Companies
Learn from the Experts
Small to medium sized companies face a host of unique challenges in the management of drug safety as they prepare to launch and sustain their products. Lack of clinical, safety and regulatory resources and expertise, along with inadequate technology infrastructure can create significant challenges and risks when advancing products through the life cycle. Find out how you can help your organizations overcome some common obstacles, learn from best practices and efficiently comply with global pharmacovigilance requirements.
David Balderson, VP of Global Safety Operations, Sciformix – A Covance Company
- David has over 20 years of experience in pharmacovigilance both in Europe with GSK and at Amgen in the US, where he was Head of Safety Operations. For the past 4 years he has been Head of Global Safety Operations at Sciformix, a Covance Company.
Bill Haddock, Head of Drug Safety, Ovid Therapeutics
- Bill is a biotech safety professional with more than 15 years’ industry experience in pediatrics, public health, epidemiology, due diligence, and benefit-risk management. He has held senior positions at Amgen as a Global Safety Officer and Biogen as a Sr Medical Director in Global Safety. He is now Head of Safety at Ovid Therapeutics.
Our experts will share best practices and provide insights on:
- Common challenges facing small and medium life science companies in support of pharmacovigilance
- Supporting EU applications: registration challenges with respect to European Medicines Agency (EMA) and EudraVigilance
- Key decision drivers for outsourcing pharmacovigilance operations
- How to optimize your model for PV by leveraging specific safety and regulatory solutions