发生这种情况时,高级管理层和团队成员对解决这些挑战的承诺(例如通过分配额外资源以及勤奋工作)都非常关键。 NDA/BLA的最终目标是获得FDA批准,因此,项目团队的每个成员都必须分担药政法规部门(Drug Regulatory Affairs,DRA)的角色。这意味着每个人都应该熟悉与其工作相关的所有审评与监管要求,并确保遵守这些要求。同样,当...
正如文首webinar系列的专用 logo 所显示的:Therapeutic Antibodies, Bench to Market,协会将充分发掘、利用协会内外部丰富的专家资源优势,邀请各相关领域的知名专家举办讲座。目前讲座包括多个专题系列:Antibody Discovery & Technology Innovation...
正如文首webinar系列的专用 logo 所显示的:Therapeutic Antibodies, Bench to Market,协会将充分发掘、利用协会内外部丰富的专家资源优势,邀请各相关领域的知名专家举办讲座。目前讲座包括多个专题系列:Antibody Discovery & Technology Innovations;Antibody-based Biologics IP Issues;Regulatory Affairs;Chemistry, Manufacturing...
Excellent strategy formulation and regulatory affairs capabilities to quickly promote the product go-to-market process in a compliant way Sound communication and exchanges with drug regulatory agencies to effectively solve key regulation issues High-quality product life cycle registration management, clear...
MD:We stay abreast and adapt to changes in regulatory policies and guidelines through constant training, participating in webinars, studying literature from regulators and other sources, and many other activities. Many of us are members of regulatory affairs professional or clinical societies, which ty...
BLABureau of Legislative Affairs BLABruno Legrand Architecture(France) BLABank Loan Agreement BLABody Loading Assembly(weapons) BLABidirectional Line Amplifier BLABlood Loss Anemia BLABracket & Linkage Assembly BLABill Low and Associates(Abbotsford, BC, Canada) ...
aRegulatory Affairs 管理事理[translate] aThe switching overvoltages on the HW line with different arresters are listed in Table 4. 开关overvoltages在用不同的逮捕的HW线在表4被列出。[translate] aGroup responsible for preparing submissions to the FDA (the IND, BLA, and NDA) and ensuring compliance...
s medical regulatory affairs group offers a wide range of services that spans the full range of product development, including training, performed by senior regulatory professionals with experience in pharmaceutical, diagnostic, device and biotechnology industries. Our medical regulatory affairs team is ...
patients and families who have supported this development program for Ryplazim®. We are committed to bringing patients potentially the first FDA-approved treatment option for C-PLGD that could make a positive difference in their lives," said Moira Daniel...
“The submission of this BLA just eight months after receiving Breakthrough Therapy Designation from the FDA provides further evidence of our commitment to delivering on patient and healthcare provider needs,” said Sabine Luik, MD, senior vice president, Medicine & Regulatory Affairs, Boehringer ...