This qualifying course is tailoured to your needs - you choose the regulatory information you need and attend the courses you like to.
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.
Our experts will update you every month with the latest updates and trends in clinical studies. Thus, you will always have essential information on the ragulatory framework, on the design and conduct of clinical trials, as well as practical tips for successful collaboration at the interfaces to other areas.
Our biotech experts will provide you with the latest information on issues related to development, quality and regulatory affairs of biologics every month in a two-hour webcast, in particular with regard to CMC.
Our global and local experts will update you every two months with the latest regulatory and legislative developments. Thus, you will always have the essential information and trends in regulatory affairs and pharmacovigilance at your fingertips!
A bi-weekly update on hot topics around data integrity in the pharma world - register now! The training course will be entirely held in English.
Our biotech experts will provide you with the latest information on issues related to development, quality and regulatory affairs of biologics every month in a two-hour webcast, in particular with regard to CMC.
Medical communication in Europe: Hot topics and pitfalls - Three experts will update you on the current requirements. Take the chance and join our online training course via Zoom. The training course will be entirely held in English.
Would you like to successfully approve and market your medical devices in China as well? Then attend our webcasts and learn more about market potential and product approvals. Our local experts will provide you with comprehensive information - especially on the subject of approval and risks that exist for European medical device manufacturers or importers.
This two-day course provides an introduction to medical writing for pharmacovigilance, as well as insights into several relevant safety documents.
The diversity of PV-relevant regulations defining the art of good PV practice call for a finely tuned balance to ensure that all PV systems employed by a company tie into a unified and truly global PV matrix. Our experts in this course will give you a detailed update on the current legal and regulatory background and on your duties.
Our biotech experts will provide you with the latest information on issues related to development, quality and regulatory affairs of biologics every month in a two-hour webcast, in particular with regard to CMC.
Our global and local experts will update you every two months with the latest regulatory and legislative developments. Thus, you will always have the essential information and trends in regulatory affairs and pharmacovigilance at your fingertips!
During this summer school you will build a solid toxicological know-how basis and will be informed about the inclusion of toxicological data in the marketing authorisation dossier. Take the chance and participate in our interactive online training.
Our biotech experts will provide you with the latest information on issues related to development, quality and regulatory affairs of biologics every month in a two-hour webcast, in particular with regard to CMC.
The course provides practical, hands-on experience in eCTD specifications, eSubmission requirements and data integrity for IDMP, SPOR and XEVMPD. Save your place in our virtual zoom seminar room.
After completing this online seminar, participants will be aware of the key regulatory requirements when preparing texts, with a greater awareness of the importance of proper English writing, reviewing and proofreading processes.
Our biotech experts will provide you with the latest information on issues related to development, quality and regulatory affairs of biologics every month in a two-hour webcast, in particular with regard to CMC.
Our global and local experts will update you every two months with the latest regulatory and legislative developments. Thus, you will always have the essential information and trends in regulatory affairs and pharmacovigilance at your fingertips!
After having attended this online seminar, you will be aware of the key components of RI and its practical use in your role as a regulatory professional.
Learn the essentials of the MDR and how to navigate around the legislation and to apply it.
An online seminar to discuss real cases/challenges for marketing authorisation in Mexico, Argentina, Colombia, Peru, Chile and Brazil with local experts from Brazil and Spain.
CMC requirements in Latin America with focus Brazil, Mexico, Colombia, Argentina, Chile and Peru - Register now and participate online! This course may be booked separately or as a module in combination with the 2-day course "Marketing Authorisation in Latin America" (22092610) (special rate available).
Compassionate Use Programme (CUP) and Named Patient Programme (NPP) - the expertise required to plan and conduct expanded access programmes.
Learn how to effectively organise multinational clinical trials for medical devices in the US, Europe and China in accordance with the international standard (ISO 14155).
Our biotech experts will provide you with the latest information on issues related to development, quality and regulatory affairs of biologics every month in a two-hour webcast, in particular with regard to CMC.
This online training will give you in-depth knowledge on the CMC requirements for marketing authorisation. Take the chance to participate in our virtual seminar via Zoom.
Essential know-how on the current regulatory framework of the various countries will be addressed in this seminar.
Our online course will provide insights into the current (remote) pharmacovigilance inspection strategy in Europe. Learn all you need to know about the differences in the inspections and about the different requirements in this training. Save your place in our virtual seminar room.
Our biotech experts will provide you with the latest information on issues related to development, quality and regulatory affairs of biologics every month in a two-hour webcast, in particular with regard to CMC.
Our global and local experts will update you every two months with the latest regulatory and legislative developments. Thus, you will always have the essential information and trends in regulatory affairs and pharmacovigilance at your fingertips!
Get your quality-related regulatory update 2022/23 here - Day I: Update from authorities and working parties, day II: Update CMC requirements in non-EU regions, as China, Japan, India, Brazil, Mexico, Russia/EAEU (experts with local know-how). Take the chance and discuss your current daily business challenges with our experts and your colleagues. Both days may be booked seperately!
Get your know-how on creating and maintaining quality data for biotech products in our online training via Zoom.
Our biotech experts will provide you with the latest information on issues related to development, quality and regulatory affairs of biologics every month in a two-hour webcast, in particular with regard to CMC.
Would you like to successfully resist on Chinese market for medical devices? Then attend our webcasts and learn more about the new Chinese regulation for medical devices, how to perfect your pre-market registration and post-market surveillance: Our local experts will provide you with brandnew information!
This e-Learning programme will provide you with detailed knowledge on the classification, grouping and submission of variations in the EU.
This e-learning programme will familiarise you with the regulatory affairs principles involved in applying for a marketing authorisation in Europe (MRP, DCP, CP) . It will also introduce you to post-authorisation duties (renewal, variation...).
Do you need know how regarding CTD/eCTD & CMC? Then this e-learning programme is the fast track to becoming knowledgeable in this field. No prior dossier experience is required.
This e-learning will familiarise you with the regulatory affairs principles outside the ICH region and show you how to categorise the various regions in terms of regulatory requirements. Dossier requirements in Australia, Hong Kong, India, South Korea, Taiwan, Saudi Arabia, GCC, Jordan, Turkey, Thailand, China, South Africa, Russia, Kazakhstan, Eqypt, Brazil, Mexico & Argentina will be addressed
This e-Learning programme will focus on stability testing for chemical and biological products in the ICH region.
This e-Learning programme will familiarise you with the data requirements in CTD Module 3.
e-Learning course with six modules on how to initiate and manage collaborations with patients and patient organisations successfully.
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