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
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.
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.
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.
Digital Transformation in Medical Affairs
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.
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.
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"!
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!
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!
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.
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
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.
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.
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.
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.
FDA inspection readiness: Gain the knowledge and skills necessary to manage future FDA inspections with confidence and ease.
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.
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!
Get your know-how on creating and maintaining quality data for biotech products in our online training.
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!
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.
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!
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!
Success in generic drug market access and pricing in Europe - register now!
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 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.
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.
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 seminar on Market Access & Pricing in Europe - this is how you can gain access as a pharmaceutical manufacturer!
This e-Learning programme will focus on stability testing for chemical and biological products in the ICH region.
This e-Learning programme will familiarise you with the data requirements in CTD Module 3.
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 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...).
This e-Learning programme will provide you with detailed knowledge on the classification, grouping and submission of variations in the EU.
With our e-learning specially tailored to medical device consultants, you will receive the knowledge essential for medical device advisors - so that you can move about in your everyday professional life with legal certainty!
This e-learning provides a comprehensive understanding of reimbursement in the German healthcare market, covering outpatient and inpatient sectors, digital health applications, and upcoming changes like hybrid DRGs and hospital reform. Stay informed and up-to-date on these significant changes in the German healthcare system.
The e-learning provides a comprehensive understanding of the German healthcare system, market access and reimbursement of medical devices, with a particular focus on the NUB process. Get insider knowledge from our speaker and place your product successfully on the German market.