2nd Bioequivalence Summit – 2nd Bioequivalence Summit

ExL Events will be running the meetings as scheduled. The official forecast path for the center of Joaquin no longer includes the U.S. East Coast. We will continue to keep a close monitor of the storm and please plan extra time for travel accordingly.

Gustavo Mendes Lima Santos

“Anvisa Regulations in Bioequivalence and Biowaivers: Trends and Challenges”

Gustavo Mendes Lima Santos
Coordinator of Therapeutic Equivalence Coordination

Recent changes in the healthcare system have put a greater focus on the development and availability of generic drugs. The pharmaceutical industry has responded by exploring alternative delivery methods, creating new test designs and, most notably, developing the first American biosimilar. These advances have been met with acclaim, but they do bring new challenges. Regulatory ambiguity in testing procedures delay generic developers, and legal action from originator drug companies restricts those focusing on biosimilars. This summit will further explore the scientific necessity of this subject, while guiding experts through their collective difficulties.

Exl Events’ 2nd Annual Bioequivalence Summit is the industry’s premier event offering all-inclusive technical and regulatory solutions for demonstrating bioequivalence in generics and biosimilars.

Top Five Reasons to Attend

  1. Learn innovative testing and modeling procedures that cut cost and provide more accurate results
  2. Hear advances in FDA regulations and requirements for ANDAs and biosimilars
  3. Discuss highly demanded alternative delivery methods, such as long-acting injectables and topical applications
  4. Understand legal challenges from originator drug companies that impact the development of biosimilars
  5. Hear the latest in current drug development issues, such as oncology and abuse-deterrent innovation

Who Should Attend

The 2nd annual Bioequivalence Summit is of interest to professionals from pharmaceutical, biotechnology and medical device companies with responsibilities involving:

  • Pharmacokinetics/Pharmacodynamics/Drug Metabolism/PKDM
  • Pharmaceutics/Biopharmaceutics
  • Drug Discovery
  • Drug Delivery
  • Preclinical Research
  • Formulation
  • Preformulation
  • Biostatistics
  • Life Cycle Management

This event is also of interest to:

  • CROs
  • CMOs
  • Central Labs
  • Regulatory Consultants
  • Statistical Service Providers
  • API Suppliers