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 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!
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 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!
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.
This ExpertFORUM focuses on safety labelling and the digitalisation of product information. Get the latest news on UNICOM, the IMI Gravitate Health project, ePI and much more
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!
The essentials in Medical Writing the Clinical Study Report (CSR)
Get your quality-related regulatory update 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!
Successful Pharmaceutical Launch in Germany
Medical Devices: Marketing authorisation and market access in Saudi Arabia, the UAE and Jordan. Don't miss out on this unique course! First-hand information provided by experienced speakers to guarantee market success of your enterprise.
Get your know-how on creating and maintaining quality data for biotech products in our online training.
What's new in the field of medical devices? What challenges do we face and how can we solve them? What are the innovations of tomorrow? Discuss, network and get impulses from our experts of the medtech sector!
Do you need essential European regulatory affairs knowledge? This online training course gives you a compact overview about all important issues. 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.
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 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 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 programme will provide you with detailed knowledge on the classification, grouping and submission of variations in the EU.
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.
e-Learning: Market Access for Medical Devices - The NUB Process
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!
Our experts will help you to identify risks in your PV system and will provide you with helpful methods to adjust your audit processes and strategies. Save your place in our virtual seminar room.
You would like to feel more secure writing CMC documents? Our experts will provide you with practical tipps and tricks and share their experiences with you. After attending this virtual seminar you will be able to present data clearly and in compliance with the regulations.
Update your knowledge: Our team of experts provides you with important and practical information about the tasks and responsibilities of an EU-QPPV.
Online Seminar about Generic Drugs: Market Access and Pricing in Europe
During this winter 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.
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.
Meet the experts Dr Ulrich Granzer and Dr Scott Oglesby and get first-hand information, hints and tips for your daily business challenges with FDA approval of a medicine for the US market!
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!
Here you will get useful information for your marketing authorisation and the CMC requirements in Japan. It includs also abridged procedures and cultural considerations
Tips & tricks for managing periodic reports and risk management plans post marketing authorisation. Furthermore insights into global PV document management will be given. Thus the training course gives you an allround overview.
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.
Variation regulation, classification guideline, eSubmission, variation management: All processes explained in this online course. Save your place in our virtual zoom seminar room! The training course will be entirely held in English.
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!
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!
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 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 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 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!
