Panel Discussion: Harmonizing a Complex Regulatory Environment

Time: 12:00 pm
day: Regulatory - AM

Details:

• Reviewing areas of similarities and differences in approaches to streamlining clinical development, including in the use of global expedited programs
• Identifying areas of whitespace for global regulatory convergence
• Outlining the collaborative steps needed to encourage regulatory convergence

Speakers:

Shinichi NODA Dr. Shinichi NODA has joined PMDA since 2009, and now he serves as the Deputy Review Director at the Office of Cellular and Tissue-based Products Read more

Michael Lehmicke Michael joined ARM in 2019 as its first Director of Science and Industry Affairs. Michael has over 20 years of R&D experience in biomaterials, medical Read more

Denise Gavin Denise Gavin, Ph.D., is the Director of the Office of Gene Therapy, in the Office of Therapeutic Products at the Center for Biologics Evaluation and Read more