Events for „Regulatory affairs & vigilance“

Further your education with our high-quality courses on regulatory affairs, pharmacovigilance and CMC. We provide excellent speakers and top-notch materials.

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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 01/01/-31/12/2025
Qualification Course: EU Regulatory Affairs Manager

Participants in this qualification course will receive thorough training on the main regulatory duties, from marketing authorisation applications to lifecycle management. This is the ideal preparation for starting a career in drug regulatory affairs. After course completion a certificate will be awarded.

online 26/03/-04/06/2025
An Introduction for Pharmacovigilance Managers

Are you new to pharmacovigilance and looking to kick-start your career? Then this online course is just for you. Gain a comprehensive overview of pharmacovigilance, regulatory requirements in the EU and implementation in only two days. Book now!

online 28-29/04/2025
online 20-21/10/2025
Webcast series: Global regulatory requirements for drug device combination products (DDCs)

Global regulatory requirements for drug device combination products (DDCs): You will receive a regulatory overview for the EU, the US, China, MENA, Mexico and other LATAM countries, plus you will obtain tips and tricks by (local) experts on how to speed up the approval process.

online 29/04/-27/08/2025
Marketing Authorisation Documents in the EU

This seminar provides an in-depth exploration of the marketing authorisation dossier and the electronic submission process, focusing on the CTD structure and Modules 1-5. Participants will gain practical knowledge and strategies for successful drug approval applications in the EU.

online 08-09/05/2025
Medical Writing in Pharmacovigilance

Enhance your skills in writing key pharmacovigilance safety documents. In this two-day online seminar, you will gain a comprehensive understanding of the regulatory requirements and hands-on experience in crafting and maintaining PSUR, RMP, and DSUR. Learn best practices, avoid common pitfalls, and address global challenges to become a proficient "Pharmacovigilance Writer"!

online 19-21/05/2025
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 and get qualified.

online 22-23/05/2025
Marketing Authorisation and Market Access in the Middle East

This face-to-face event offers a comprehensive overview of marketing authorisation and market access in the Middle East, covering key topics like market entry, intellectual property, lifecycle management, pharmacovigilance and quality considerations, with a focus on Gulf Cooperation Council, Saudi Arabia, the UAE, Jordan and Syria.

Frankfurt 26-27/05/2025
Biopharmaceuticals

The compact course with a content focus on the development, production and analytics of biotech drugs. Secure your place and qualify now! All three course days can be booked individually (single day = 1.290€ plus VAT) - for booking, please contact us!

online 03-05/06/2025
Regulatory Lifecycle Management

This course familiarises you with regulatory post-approval duties and provides first-hand information on variation submission, PV activities and labelling changes.

online 04/06/2025
International Medical Device Regulations

This online course offers an in-depth overview of the medical device approval process in key global markets: Regulatory strategies, approval steps and timelines for global market access, with a focus on North and South America, the Asia-Pacific region and China.

online 26-27/06/2025
The GVP Refresher

The Good Pharmacovigilance Practices modules (GVP modules) by the European Medicines Agency (EMA) serve as a reference for standard practices in pharmacovigilance. This online course serves as a refresher and ensures that you are up to date with the best practices.

online 03-04/07/2025
Artificial Intelligence in Pharmacovigilance

Join our interactive course to explore how AI is transforming pharmacovigilance. Take part in discussions, hands-on workshops, and case studies while diving into AI technologies, regulations, and their applications in drug safety. Register now to participate, share insights, and collaborate with peers!

online 10/07/2025
Regulatory Affairs and GMP compliance in Eastern Europe

This online training offers comprehensive insights into Regulatory Affairs, CMC, and GMP requirements, with a focus on the latest updates and developments in EAEU countries.

online 28-29/08/2025
Medical Devices for Beginners

This seminar provides newcomers and career changers with a comprehensive introduction to European and national medical device regulations. Participants gain essential knowledge on development, classification, clinical evaluation, and post-market surveillance of medical devices. Our preparatory e-learning ensures optimal readiness for the seminar and helps deepen the practical understanding.

online 04-05/09/2025
Global CMC requirements: focus on Asia, Japan, and Eastern Europe

Four live webcasts à 2 hours every week: CMC requirements in China, India, Japan, South Korea and Russia/EAEU. Meet our four experts to get an update on the current requirements in the different regions and discuss your individual issues with them. You are interested in one webcast only or a group account? Contact us!

online 16/09/-07/10/2025
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. Register today!

online 18/09/2025
APIs in Regulatory Affairs

Are you a specialist in the pharmaceutical industry in the area of marketing authorization and responsible for compiling the quality documentation of active pharmaceutical ingredients (APIs) and their starting material? Then this is the right online seminar for you!

online 22-23/09/2025
CTD: requirements for non-clinical/clinical modules and eCTD-readiness

Non-clinical/clinical content in the dossier: Are you a beginner in the field and would like to feel confident working competently on modules 2, 4 and 5 in the future? Are you already an experienced specialist and would like to refresh, professionalise or "structure" your knowledge? Then you've come to the right place!

online 24-25/09/2025
Masterclass: Local QPPV, EU QPPV, and Head of PV

Due to high demand - now available in English Are you experienced in pharmacovigilance and looking for in-depth knowledge on managing a PV system and leading your team? Do you have specific questions about your role as responsible person? Then this online event is for you! Gain insights and expertise - from experts for experts.

online 25/09/2025
Pharmacovigilance Key Performance Indicators

Are you involved in the implementation and ongoing adaptation of the PV system? In this online course you will learn how to use the right Key Performance Indicators (KPIs) for your PV system in a profitable way. Reserve your seat now and be part of this insightful session!

online 06/10/2025
CMC dossier requirements: FDA vs EU

CMC dossier requirements FDA vs EU: After having attended the seminar you will feel secure writing and maintaining the quality dossier for US marketing authorisations of small and large molecules (chemicals and biologic).

online 07/10/2025
An Introduction for Pharmacovigilance Managers

Are you new to pharmacovigilance and looking to kick-start your career? Then this online course is just for you. Gain a comprehensive overview of pharmacovigilance, regulatory requirements in the EU and implementation in only two days. Take the next step in your professional growth - enrol now!

online 20-21/10/2025
online 28-29/04/2025
Pharmacovigilance Auditing

Do you want to independently plan and conduct pharmacovigilance audits? Then take this opportunity to become an "Auditor for Good Pharmacovigilance Practices". Secure your place on our compact, interactive online course. Book now!

online 27-28/10/2025
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 at your fingertips!

online
CMC for Biologicals

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

online 06/11/2025
Pharmacovigilance Project Management

- Newly designed and engagingly structured - This application-oriented online seminar is designed for pharmacovigilance professionals responsible for drug safety projects or those actively involved in project teams. Learn practical project management skills and benefit from discussing case studies in pharmacovigilance step by step.

online 11-13/11/2025
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 and get qualified.

online 20-21/11/2025
Hot Topics Related to Quality in Herbal Medicinal Products

Experts from national competent authorities speak about the current developments with regard to e.g. the revision of guidelines (GACP, Variation Regulation, Variation Classification Guideline), the changes of procedures and corresponding chances (MRP/DCP), and the use and "impact" of new evaluation methods (Real World Data). The authority's prespective is complemented by industry's experiences.

online 27/11/2025
Global CMC requirements: focus on Latin America/Latam countries

CMC requirements in Latin America with focus Mexico, Brazil, Colombia, Argentina, Chile, and Peru. The seminar (2 half days) is comfortable to integrate into your daily work routine.

online 01-02/12/2025
Preclinical development: From bench to first in human

Preclinical drug development: The online training course for preclinical newcomers with a focus on small molecules and biologics. Learn about the fundamentals and regulatory requirements and take the opportunity to discuss the challenges in your practice with our experts and industry colleagues.

online 09-11/12/2025
Advanced class: The Global Network of Local and Regional QPPVs

Are you a QPPV, local Safety Officer, or part of a QPPV office within an international MAH? Looking for a targeted training course to improve your day-to-day activities and collaboration with other PV professionals? This seminar shows you how.

online 11/12/2025
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
e-Learning: Common Technical Document and 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: 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: EU Variation System and Procedures

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

online