Attend one of our free pre-meetings to familiarise yourself with the Learning Space and the various ways in which you can interact during the event
This e-Learning programme will focus on stability testing for chemical and biological products in the ICH region.
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.
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.
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.
The conference will cover recent updates and practical implications of the EU pharmaceutical legislation, the application of AI in RA, and the new EU Variation regulation. Additionally, it will address the latest developments in quality (draft) guidelines: ICH M13a and M13B, ICH M4Q(R2), EU GMP Annex 11, New Annex 22 on AI, and an update on the ongoing discussions on nitrosamine "contaminations".
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!
During our online training "Toxicology and beyond: Safety assessment in drug development" 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.
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.
Gain strategic insights into utilizing prior use rights across multiple jurisdictions in this practical course. Learn to assert defense rights effectively before the UPC, EPO, and national courts in Germany, China, and the US, through the analysis of diverse case studies.
This online seminar provides a comprehensive overview of global regulatory affairs, covering strategies for setting regulatory policies, developing global regulatory dossiers, understanding HTA interfaces, enhancing global communication, and staying updated on ICH guidelines, ISO IDMP updates, and global regulatory trends.
