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.
This online training will give you in-depth knowledge on the CMC requirements for marketing authorisation. Including an update on the new (Draft) ICH M4Q(R2) and the Draft of the Revision of the Classification Guideline. Take the chance to participate in our virtual seminar and get qualified.
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.
Our experienced speakers will help you prepare for all the challenges facing board members in German banks. Including Fit & Proper requirements for management board members according to § 25c KWG, new BaFin circular on FAP (fit and proper) of October 22, 2025.
Our experienced speakers will help you prepare for all the challenges that supervisory boards face. Including Fit & Proper requirements for supervisory board members according to § 25c KWG, new BaFin circular on FAP (fit and proper) of October 22, 2025.
This online course shall provide a sound overview about different local laws in important countries in EU and beyond with respect to employee invention rights. It shall enable the participants to address complex situations when designing and negotiating agreements for cross-border R&D.
This course provides drafting and negotiating advice for EU practitioners, with precise references to existing US law.
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".
