With this qualification course, you can continue your education in a structured manner in all CMC topics, with a technical focus on development methods, manufacturing processes, CMC documents, change management, and much more.
Global regulatory requirements for drug device combination products (DDCs): You will receive a regulatory overview for the EU, the US, China, MENA, Mexico and other LATAM countries, plus you will obtain tips and tricks by (local) experts on how to speed up the approval process.
This online course offers an in-depth overview of the medical device approval process in key global markets: Regulatory strategies, approval steps and timelines for global market access, with a focus on North and South America, the Asia-Pacific region and China.
The Good Pharmacovigilance Practices modules (GVP modules) by the European Medicines Agency (EMA) serve as a reference for standard practices in pharmacovigilance. This online course serves as a refresher and ensures that you are up to date with the best practices.
Join our interactive course to explore how AI is transforming pharmacovigilance. Take part in discussions, hands-on workshops, and case studies while diving into AI technologies, regulations, and their applications in drug safety. Register now to participate, share insights, and collaborate with peers!
This online training offers comprehensive insights into Regulatory Affairs, CMC, and GMP requirements, with a focus on the latest updates and developments in EAEU countries.
This seminar provides newcomers and career changers with a comprehensive introduction to European and national medical device regulations. Participants gain essential knowledge on development, classification, clinical evaluation, and post-market surveillance of medical devices. Our preparatory e-learning ensures optimal readiness for the seminar and helps deepen the practical understanding.
Variation regulation, classification guideline, eSubmission, variation management: All processes explained in this online course.
Four live webcasts à 2 hours every week: CMC requirements in China, India, Japan, South Korea and Russia/EAEU. Meet our four experts to get an update on the current requirements in the different regions and discuss your individual issues with them. You are interested in one webcast only or a group account? Contact us!
This online-seminar will provide tips on how to prepare and maintain a core PSMF as well as annexes with the relevant local peculiarities worldwide. Register today!
Are you a specialist in the pharmaceutical industry in the area of marketing authorization and responsible for compiling the quality documentation of active pharmaceutical ingredients (APIs) and their starting material? Then this is the right online seminar for you!
