Presentations for „Regulatory affairs & vigilance“

Our regulatory courses and conferences provide practical information on the fundamentals and trends in marketing authorisation, regulatory maintenance and post-marketing surveillance.

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Modular e-Learning and webcast Access possible at any time
Qualifying Course: Global Regulatory Affairs Manager

This qualifying course is tailoured to your needs - you choose the regulatory information you need and attend the courses you like to.

online
Qualification course: CMC-Specialist in Regulatory Affairs

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.

online
PharmaFORUM Webcast Biologics "Digitalization/ Personalization of Healthcare"

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.

online
PharmaFORUM Webcast International "Marketing Authorisation of Drugs in Iraq/Iran"

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
PharmaFORUM Webcast Biologics "Lifecycle considerations for analytical methods"

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.

online
PharmaFORUM Webcast Biologics "Regulatory support in pharmaceutical development - exchange with regulators from Bench to Bedside"

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.

online
PharmaFORUM Webcast International "A company's QPPV Network"

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
PharmaFORUM Webcast Biologics "Trends in preclinical studies on pharmacology/toxicology"

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.

online
CMC Management in Regulatory Affairs

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.

online 13-14/10/2022
ExpertFORUM Labelling

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

online 20-21/10/2022
Pharmacovigilance Inspection Readiness

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 24/10/2022
PharmaFORUM Webcast Biologics "Post-approval change management protocols"

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.

online
online 01/07/-30/06/2023
online 01/08/-31/07/2023
online 01/09/-31/08/2023
online 01/10/-30/09/2023
online 01/12/-30/11/2023
online 01/01/-31/12/2023
online 01/04/-31/03/2024
online 01/06/-31/05/2024
online 01/08/-31/07/2024
online 01/09/-31/08/2024
online 01/10/-30/09/2024
online 01/11/-31/10/2024
Annual CMC Conference

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!

online 09-10/11/2022
Marketing Authorisation of Medical Devices in Saudi Arabia, the UAE and Jordan

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.

online 17/11/2022
CMC for Biologicals

Get your know-how on creating and maintaining quality data for biotech products in our online training.

online 22/11/2022
FORUM MedTech Days 2022

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!

online 29-30/11/2022
EU Regulatory Affairs introductory training course

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.

online 29/11/-01/12/2022
Masterclass China: Medical Device Marketing Authorisation for Advanced

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!

online 06-07/12/2022
e-Learning: Marketing Authorisation Outside the ICH Region

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

online
e-Learning: Introduction to EU Marketing Authorisation

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...).

online
e-Learning: Common Technical Document & eCTD

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.

online
e-Learning: EU Variation System & Procedures

This e-Learning programme will provide you with detailed knowledge on the classification, grouping and submission of variations in the EU.

online
e-Learning: Stability Testing in the ICH Region

This e-Learning programme will focus on stability testing for chemical and biological products in the ICH region.

online
PharmaFORUM Webcast Biologics "Regulatory Requirements for Combinations of Drugs and Devices"

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.

online
PharmaFORUM Webcast International "Marketing authorization maintenance in LATAM"

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
Risk based PV audits

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.

online 19/01/2023
CMC Writing

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.

online 02/02/2023
The EU Qualified Person for Pharmacovigilance (EU-QPPV)

Update your knowledge: Our team of experts provides you with important and practical information about the tasks and responsibilities of an EU-QPPV.

online 06/02/2023
The Pharmacovigilance System Master File (PSMF) in a Global Environment

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.

online 27/02/2023
Regulatory Affairs in the US

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!

online 28/02/-01/03/2023
PharmaFORUM Webcast International "Global CMC Strategy"

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
Regulatory Affairs for Pharmaceuticals in Japan

Here you will get useful information for your marketing authorisation and the CMC requirements in Japan. It includs also abridged procedures and cultural considerations

online 21-22/03/2023
RMP and PSUR in life-cycle management: An art, not a miracle

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.

online 22/03/2023
PharmaFORUM Webcast Biologics "Questions at the interface of CMC and non-clinics - how to contribute to successful non-clinical drug development"

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.

online
Variations in Europe

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.

online 17-18/04/2023
PharmaFORUM Webcast International "Coordination of international maintenance activities - Variations Management globally"

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
PharmaFORUM Webcast Biologics "Filing for a BLA vs MAA application with focus on the CMC requirements"

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.

online
PharmaFORUM Webcast International "Regulatory Affairs Maintenance in China - Annual Report"

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
PharmaFORUM Webcast Biologics "MA in Brazil with a focus on 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.

online
PharmaFORUM Webcast Biologics "The new Clinical Trial Regulation and the Go-Live of Clinical Trial Information System (CTIS)"

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.

online
PharmaFORUM Webcast Biologics "Advantages and disadvantages of different approval procedures (MRP/DCP/CP)"

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.

online
PharmaFORUM Webcast Biologics "Hospital exemption in the initial application and regulatory context"

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.

online
PharmaFORUM Webcast International

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