This online training addresses the needs of regulatory affairs managers dealing with marketing authorisations outside the EU or planning to do so in the future.
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 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.
All the essentials of clinical trials in Europe in only two days! Six experts will share their in-depth knowledge with you to introduce you as beginner or update you as professional on the most important aspects. Pose your individual questions in advance or live to make the most of your training!
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!
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.
This online training programme consisting of three recorded webcasts will train you how to develop documents, compile them and submit an eCTD step by step.
This e-Learning programme will provide you with detailed knowledge on the classification, grouping and submission of variations in the EU.
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.
Do you need to be well versed in European pharmacovigilance for your daily work? Then we recommend this e-Learning. You can choose between three different packages according to your level of expertise and requirements.
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!
Evidence generation, value proposition and the HTA - the latest insights with regard to Orphan Drugs
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.
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.
Update your knowledge: Our team of experts provides you with important and practical information about the tasks and responsibilities of an EU-QPPV.
Meet the expert Dr. Ulrich Granzer and get first-hand information, hints and tips for your daily business challenges with FDA approval of a medicine for the US market!
This workshop helps you collect, clean and structure all necessary data for IDMP and informs you on ePI (structured electronic product information) - a digitalisation project potentially utilizing IDMP and SPOR
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.
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.
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.
Online Seminar about Generic Market Access & Pricing in Europe
Compassionate Use Programme (CUP) and Named Patient Programme (NPP) - the expertise required to plan and conduct expanded access programmes.
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!
Online Seminar series about Market Access & Pricing in EU5 countries
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).
Three experts will give you an in-depth update on your duties with regard to accepted clinical trial data, dossier submission and the post-approval processes in CHINA. Including the latest eCTD specifications of TAIWAN.
How to prepare effectively for the responsibilities of a person responsible for regulatory compliance (PRRC). This and more in our online-seminar via Zoom!
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 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.
Here you will get useful information for your marketing authorisation and the CMC requirements in Japan. It includs also abridged procedures and cultural considerations
Effective oversight of outsourced activities in the healthcare sector - Prepare yourself for the balancing act between compliance and outsourcing, and learn how to implement your own effective regulatory vendor oversight programme. Save your place today.
This online training provides you with in-depth knowledge on marketing authorisation, CMC and GMP requirements in Russia, Belarus, Kazakhstan and Ukraine. These are your booking options: Day I+II (basic training course): € 1.690,00 (+ German VAT), Day III (focus GMP, course may be booked separately): € 1.090 (+ German VAT), Day I-III: € 2.480,00 (+ German VAT)
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!
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.
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 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!
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 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!
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.
This online training provides you with in-depth knowledge on marketing authorisation, CMC and GMP requirements in Russia, Belarus, Kazakhstan and Ukraine. These are your booking options: Day I+II (basic training course): € 1.690,00 (+ German VAT), Day III (focus GMP, course may be booked separately): € 1.090 (+ German VAT), Day I-III: € 2.480,00 (+ German VAT)
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!
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.
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...).
e-Learning course with six modules on how to initiate and manage collaborations with patients and patient organisations successfully.
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