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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Global Regulatory Affairs Manager

With this qualification course, you can continue your education in a structured manner in all global regulatory affairs topics, with a regional or country-specific focus.

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
Regulatory Affairs and GMP compliance in Eastern Europe

Get know-how on the LATEST CHANGES (EECC 114) in the EAEU Upgrade Procedure - This online training provides you with in-depth knowledge on Regulatory Affairs, CMC and GMP requirements in EAEU countries.

online 15-16/04/2024
Pharmacovigilance Inspection Readiness

Learn how to prepare your pharmacovigilance system in Germany, Europe and worldwide for an upcoming inspection in this one-day online course. Gain a comprehensive understanding of the EMA's Good Pharmacovigilance Practice (GVP/GPvP) modules, strategic and remote planning and preparation, and differences in GVP inspections around the world. Reserve your seat in our virtual seminar room.

online 22/04/2024
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 15-16/05/2024
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 04-05/06/2024
EU Regulatory Affairs Introductory Training Course

Do you need essential European regulatory affairs knowledge? This online training course gives you a compact overview on all important issues. The training course will be entirely held in English.

online 05-07/06/2024
Medical Writing in Pharmacovigilance

Enhance your skills in writing key pharmacovigilance safety documents. In this two-day online seminar, gain not just a broad understanding of the regulatory requirements and guidelines, but also practical experience in crafting and maintaining PSUR, RMP, and DSUR. Learn best practices, discover common pitfalls, and tackle global challenges to become a proficient "Pharmacovigilance Writer"!

online 06-07/06/2024
Pharmacovigilance Requirements in China - LATAM - EAEU - MENA

Regulatory expectations regarding risk management for pharmaceuticals in (emerging) markets often contend with the stringent standards set by the EU/ICH regions. Join us in five consecutive webcasts to gain insights into local pharmacovigilance systems in different countries and regions, and learn how to integrate them into your global PV system while maintaining a clear overview!

online 10-11/06/2024
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 (a single day of your choice = 1.190€ plus VAT) - for booking, please contact us!

online 24-26/06/2024
Artificial Intelligence in Pharmacovigilance

Artificial intelligence is being hailed as the next key innovation. This course will show you how to integrate suitable systems and applications into your daily workflow and simplify business processes between your PV and IT departments using AI. Register now to stay ahead.

online 05/07/2024
Masterclass China: Medical Device Marketing Authorisation for Advanced

Interested in establishing a strong presence in the Chinese medical devices market? Join our training to gain valuable insights into the latest Chinese regulations governing medical devices, and discover strategies to optimize your pre-market registration and post-market surveillance. Benefit from the expertise of our local specialists, who will share up-to-date information to enhance your success

online 10-11/09/2024
Webcast series "Development of RNA-based drugs and oligonucleotides"

RNA-based drugs and oligonucleotides: gain a solid understanding of the complexities involved in the development and regulatory approval of RNA-based drugs and oligonucleotides. Meet outstanding and longtermin experienced experts in the field of research.

online 11/09/-11/12/2024
GxP-Regulated Archiving

Get practical expertise for the GMP, GLP and GCP-compliant archiving of relevant documents and the efficient integration of the archiving system into your daily work processes. The three experts will show you some practical approaches to typical pitfalls.

online 24/09/2024
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 26-27/09/2024
Mastering FDA inspections: Preparation and Best Practices

FDA inspection readiness: Gain the knowledge and skills necessary to manage future FDA inspections with confidence and ease.

online 15/10/2024
CMC dossier requirements for biologics: FDA vs EU

CMC requirements in the US: After having attended the seminar you will feel secure writing and maintaining the quality dossier for US marketing authorisations of large molecules/biologics.

online 23/10/2024
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 04/11/2024
RMP and PSUR in lifecycle management: An art, not a miracle

Do you already have a good understanding of PSUR and RMP including risk minimisation measures and would like to deepen, broaden and update your knowledge? Then this course is for you! Learn about pharmacovigilance requirements in the drug lifecycle and their impact on RMP and PSUR from a global perspective. Save your place now!

online 06/11/2024
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 12-13/11/2024
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 12-13/11/2024
Mastering ICH Quality Guidelines: From Development to Lifecycle Management

To make the most of ICH Q12 opportunities, you have to be aware of the relation between ICH guidelines Q8 to Q12 and how to properly integrate them. Our experts will go through each guideline and train you on the desired outcome of mastering the processes from development to lifecycle management and especially QbD.

online 28/11/2024
PharmaFORUM Webcast Biologics 2024

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.

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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 09-11/12/2024
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...).

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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