Presentations for „Online-Training“

Modular e-Learning and webcast Access possible at any time
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.

Webcast series: All about Data Integrity

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.

Medical communication in Europe

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.

online 21.06.2022
Medical Devices in China

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.

online 21. - 22.06.2022
Medical Writing in Pharmacovigilance

This two-day course provides an introduction to medical writing for pharmacovigilance, as well as insights into several relevant safety documents.

online 22. - 23.06.2022
Pharmacovigilance Requirements in China - LATAM - Russia - MENA

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.

online 27. - 28.06.2022
eSubmission Management in Europe

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.

online 30. - 31.08.2022
Crash Course: Medical Device Regulation

Learn the essentials of the MDR and how to navigate around the legislation and to apply it.

online 08.09.2022
Marketing Authorisation in Latin America

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.

online 19. - 20.09.2022
CMC requirements in Latin America

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).

online 21. - 22.09.2022
Expanded Access Programmes

Compassionate Use Programme (CUP) and Named Patient Programme (NPP) - the expertise required to plan and conduct expanded access programmes.

online 22.09.2022
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 12. - 13.10.2022
Marketing Authorisation in ASIA

Essential know-how on the current regulatory framework of the various countries will be addressed in this seminar.

online 18. - 20.10.2022
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 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!

Annual CMC Conference

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!

online 09. - 10.11.2022
PharmaFORUM Webcast Biologics

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.

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: 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.

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...).

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.

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

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.

e-Learning: CTD Module 3

This e-Learning programme will familiarise you with the data requirements in CTD Module 3.