ICHGL更新从行业角度看M4QR2的期望

ICH GL Update: M4Q (R2)Expectations from an Industry Point of ViewHiroshi Ohtsuka(JPMA, Bayer Yakuhin Ltd.)1The views and opinions expressed in this presentation are those of the presenter and should not necessarily represent the views and opinions of the relevant organizations.Outline◆Missions of Pharmaceutical Industry◆Benefits of Revised M4Q◆Industry Expectations◆Considerations as industry2Missions of Pharmaceutical Industry3Five major missions of the pharmaceutical industry (by ChatGPT based AI ):1.Research and Development (R&D):Innovating and developing new drugs and therapies to address unmet medical needs and improve patient outcomes.2.Regulatory Compliance: Ensuring that all products meet safety, efficacy, and quality standards set by regulatory authorities to protect public health.3.Accessto Medications: Working to improve access to essential medicines for patients globally, especially in underserved populations.4.Sustainabilityand Ethical Practices: Committing to ethical prac