Accestra Webinars In collaboration with Pharma To Market, we invite you to join us for a complimentary webinar on 16th May 2023. Drug registration overview in China The webinar will cover these topics: China Drug Regulatory Framework China Drug Registration Overview Imported Drug Registration including overseas data acceptance and regulatory challenge Date : 16 May…
Conference Introduction RAPS Euro Convergence is the most comprehensive regulatory affairs conference in Euro. We are excited to attend the conference in Amsterdam on 10-12 May. This certainly is a valuable opportunity for regulatory affairs professionals worldwide to connect, learn from one another, discuss industry trends & best practices, and expand networks! If you are…
Time and Location: 24 – 25 May 2023 | London, UK Meet us in London, engage with our speaker face to face about China GVP and relevant regulation changes and get real-time feedback for your questions. INTRODUCTION Pharmacovigilance regulations in China are constantly evolving and rapidly changing. With China becoming increasingly important for pharmaceutical companies,…
Accestra Webinars In collaboration with Pharma To Market, we invite you to join us for a complimentary webinar on 17th April 2023. Registration of Drug Master File (DMF) in China for APIs, Excipients & Packaging Materials The China DMF registration webinar will cover these topics: China DMF Regulatory Framework China DMF Pathways Comparison between China…
The Responsible Person for Pharmacovigilance (RPPV) is the Chinese equivalent of the Qualified Person Responsible for Pharmacovigilance (QPPV) in EU and other countries. Like QPPV, the primary role of an RPPV in China is to ensure the pharmacovigilance system is following regulations and for the safety of the marketed products and serve as the primary…
ACCESTRA WILL BE PRESENTING AT THE WEBINAR “COMPARISON OF CHINA DMF WITH EU AND US” ON TOPRA. Date: 22 Feb 2023, Wednesday Time: 15:00-16:00 GMT 10:00-11:00 Eastern Time Date: 22 Feb 2023, Wednesday Time: 23:00-24:00 Beijing Time Webinar Introduction This webinar is about China Drug Master Filing (DMF) versus EU and U.S DMF. Accestra will…
China CDE director vows more support for drug review & approval in the coming years. The director of China’s Center for Drug Evaluation (CDE) has delivered a speech on Improving the Efficiency and Quality of Drug Review & Approval at the 2022 DIA China Annual Conference, with a retrospective summary of the last 5 years’…
Signal management in Pharmacovigilance is an important part in China’s Good Pharmacovigilance Practice (hereinafter “China GVP”), which was released by National Medical Products Administration (NMPA) in May 2021. “To conduct efficient activities of signal detection and assessment” is listed as a fundamental requirement for quality management in Pharmacovigilance and one of the key responsibilities of…
