The term biosimilar is a relatively recent term used in the drug manufacturing industry. However, since 2012 has become more popular and very relevant to drug manufacturing. This webinar will provide insights into what a biosimilar is and isn’t and how the current drug industry is being transformed by this growing trend in drug manufacturing. Regulatory and clinical aspects will be touched on throughout this discussion.
Key points include:
- Review Drug Product Development Stages
- Review what makes up a Biological Drug
- What makes a Biological Drug a Complex Drug
- What is a Biosimilar and What a Biosimilar is Not
- Regulatory Requirements and Product Development for a Biosimilar
- Current Biosimilar Players in the Industry and Future Players
**A Certificate of Completion will be sent to each registered Attendee following the webinar
WHO SHOULD ATTEND?
- Recent graduates in Sciences and post grades from a certified regulatory/quality assurance program
- Regulatory Affairs professionals
- R&D professionals
- Quality/Compliance professionals
SPEAKER: James Pierce, B.Sc, HONS
James Pierce is currently a Regulatory Affairs Professional with over 25 years of experience in the biological and pharmaceutical industry and has worked for some of the most recognized multinational companies (Sanofi, Amgen, Boehringer Ingelheim and GSK). Throughout his 25 years of experience, Mr. Pierce has worked in Pure Research, Research and Development, Quality Operations, Industrial Operations and Regulatory Affairs. With 18 years of biological industry experience Mr. Pierce will provide his insights and current understanding in regards to biosimilars.
|Student Ticket:||$100.00||— Sold Out|
|Non-Member Ticket:||$180.00||— Sold Out|
|Pro/Pro Plus Member Ticket:||$150.00||— Sold Out|