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.
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.
The online training with details on development, quality, CMC, approval and market access (including an update on the upcoming EU HTA) for advanced therapy medicinal products. Qualifiy now!
This seminar offers beginners in clinical project management the opportunity to gain comprehensive insight into their responsibilities as clinical project managers and to acquire both specialized project management knowledge and skills in team leadership and communication.
Join our two-day course and discover how to revolutionize your patent work with the power of generative AI. This immersive workshop offers patent attorneys, counsels, and engineers a unique opportunity to gain hands-on experience with generative AI.
This topical in-person conference is about the latest developments in artificial intelligence and intellectual property. Attendees will get insights into the 'hot' topics of this super trend from top speakers from patent offices, from the industry and from private practice.
Pharmacometric modeling in Monolix - various (guided) hands-on units included. After having participated in the hands-on course you will be prepared to tackle real-world challenges in pharmacometrics, ultimately improving your contributions to disease modeling and drug development projects.
Get your know-how on creating and maintaining quality data for biotech products in our online training. Including an outlook on the new (Draft) ICH Q1 and ICH M4Q(R2).
