アメリカでの事業展開を計画中の創薬系ベンチャー企業必見！
アメリカにおける医薬品の申請・審査プロセスに関する基礎知識を得たい方々を対象に、FDA（U.S. Food and Drug Administration）申請に精通したエキスパートであるEnith Morillo氏をお招きし、FDA申請プロセスにおける基本的な要点についてご講演していただきます。さらに、参加者からの質問や悩みにお答えするインタラクティブなコーナーもご用意しております。FDA申請プロセスを深く理解する貴重な機会をお見逃しなく！
We have invited Enith Morillo, an expert well-versed in the FDA (U.S. Food and Drug Administration) application process, to provide a lecture on the fundamental aspects of the FDA application process for those who wish to gain basic knowledge about the application and evaluation process for pharmaceuticals in the United States. Additionally, we have prepared an interactive segment to address questions and concerns from participants. Don't miss this valuable opportunity to gain a deep understanding of the FDA application process!
プログラム
17:00 - 17:03 挨拶 大江 星菜 氏/ CIC Japan, Project Associate of CIC Institute
Opening remarks
17:03 - 17:10 CIC institute、Block Buster Tokyoの事業紹介
Introduction of CIC Institute and Block Buster Tokyo
17:10 - 18:10 Lecture: Enith Morillo 氏
[Contents]
・Overview and basic procedures of the application process
・Useful resources for FDA applications
etc...
18:10 - 18:25 Q & A session :司会 大江星菜 氏 (事前質問、会場からの質問)
Q & A session with Ms. Enith Morillo (Pre-submitted questions and questions from the audience)
18:30 閉会・ネットワーキング
Conclusion and Networking
登壇者
Enith Morillo氏/ Founder, President, and Principal Consultant of Cadoret Global Inc.
Enith Morillo, M.Sc., is the Founder, President, and Principal Consultant of Cadoret Global Inc., a quality and compliance consulting firm based in Rhode Island, USA, that supports virtual, startups, and early stage and small-size pharmaceutical companies globally in taking their investigational drugs through development and into clinical trials. Cadoret Global Inc. is a women-owned and minority-owned certified business, and an alum of the reputable Goldman Sachs 10,000 Small Business program.
A native of Venezuela, Enith has a Master and Bachelor of Science in Electrical and Biomedical Engineering from Worcester Polytechnic Institute (WPI). She is an accomplished quality and compliance leader in the pharmaceutical industry, and is currently the President-elect of the New England chapter of the Parenteral Drug Association (PDA), a global organization renowned for bringing industry, regulators, and academia together.
Enith is involved in initiatives by the Japan External Trade Organization (JETRO) in helping emerging Japanese bio/pharma companies understand the US regulatory landscape. She is currently on the Advisory Board for Volunteer Morocco, and is a passionate mentor and supporter for women and minorities in STEM.
She was recently featured in Providence Business News, and regularly writes for leading industry publications.
参加費
無料