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プロジェクト・オプティマス:お客様のプログラムの促進に向けて、FDAと関与する方法

Special Live Session - in person at DIA!

Join us for this SPECIAL SESSION taking place during DIA Global 2022. This is a cocktail reception with presentation and Q&A hosted by Julie Bullock, PharmD & ex FDA and Demetrius Carter at the Hyatt Regency McCormick Place.

Given the launch of Project Optimus, how do you best navigate the evolving regulatory landscape and determine the optimal way to engage with the agency?  Join this special event at DIA 2022 to address key questions that will help you to create a plan that’s tailored to your needs, whether you are at pre-IND stage or already in the clinical phases.

  • What is the actual ask from the FDA on Project Optimus?
  • When should you engage with the agency?
  • What should you talk about with the agency and how should you prepare?
  • What are best practices for your regulatory engagement and submission?

Location: Prairie Room located on the 2nd floor of the Hyatt Conference Center

Space is limited
Register today for this in-person event at DIA 2022!

Thank you for registering for our special live session to be held on Tuesday, June 21st 5:30-7:30pm at Hyatt Regency McCormick Place (adjacent to the DIA Global conference at McCormick Place)

What to expect:

5:30 – 5:45 Refreshments

5:45 – 6:45 Presentation followed by Q&A

6:45 – 7:30 Refreshments

We will send email reminders ahead of the session.

We look forward to seeing you there!

Speakers
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Demetrius Carter
SVP, Regulatory Services, Synchrogenix, a Certara Company
Demetrius Carter, RAC, is a clinical development executive with 20+ years of drug development experience in both the pharmaceutical and medical device industries. His experience includes roles at Glaxo SmithKline, Pfizer and JNJ before transitioning into the CRO industry. While at IQVIA, Demetrius held roles of increasing responsibilities in project management, clinical monitoring, and central laboratories. He also led global operations at Syneos Health for both the medical device and the oncology business units. Demetrius presently serves as the senior vice president, regulatory services at Synchrogenix where he oversees their regulatory writing, strategy, and operations functions. He has a Bachelor of Science in Biological Sciences from North Carolina State University and an MBA from Fairleigh Dickinson University. He also holds several certifications including Project Management Professional (PMP) from the Project Management Institute, Lean Six-Sigma Green Belt Certification from Villanova University, and the Regulatory Affairs Certification (RAC).
Bio Pic JulieBullock
Julie Bullock, PharmD
Senior Vice President, Global Head of Clinical Pharmacology & Translational Medicine
米国FDAにおいて10年以上医薬品承認申請の審査に携わり、14件以上の新薬の承認に貢献してきました。小児用医薬品の開発、生物学的製剤のPK/PD解析および開発アプローチ、抗がん剤の投与戦略、画期的治療薬の開発、および迅速承認に関して深い見識を持っています。
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