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In response to industry’s need for current and reliable information on a rapidly growing area of pharmaceutical manufacturing, PDA has introduced the 2016 Biosimilars Conference. 

Discussion will focus on clinical development, process validation and product specifications for Tier 1 and Tier 2 CQAs. Presentations and case studies will illustrate how analytical similarity can be demonstrated and practical control strategies can be developed.

In addition, U.S. FDA, EMA and Health Canada regulators will present current updates and CMC reviewer perspectives will clarify those CMC issues that have been most difficult to approve.

Upon completion of the Conference, you’ll be able to:

• Discuss the challenges of global development and approval for biosimilars
• Summarize approaches for global post-marketing change control
• And more

Attendees will also have the opportunity to raise questions and concerns to be addressed by the experts during the Conference.

On June 22, immediately following the Conference, PDA Education will offer two new courses that will help you further understand the challenges that must be considered before entering the field of biosimilar manufacturing.

The Biosimilar CMC and Regulatory Challenges course will increase your appreciation of why biosimilars are not treated by the regulatory authorities as “bio-generics” and explain the totality of what is required in bringing biosimilars to the marketplace. The Analytical Method Qualification, Transfer and Validation for Biosimilars course will provide you with detailed strategies and case studies for suitable risk assessments for all method lifecycles steps and the resulting studies and protocol acceptance criteria.

Learn more and register before May 6 for the largest savings!