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.
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
Global regulatory requirements for drug device combination products (DDCs): You will receive a regulatory overview for the EU, the US, China, MENA, Mexico and other LATAM countries, plus you will obtain tips and tricks by (local) experts on how to speed up the approval process.
This e-Learning programme will provide you with knowledge on Good Distribution Practice in today's pharmaceutical industry
This e-Learning programme will familiarise you with the data requirements in CTD Module 3.
This e-Learning programme will focus on stability testing for chemical and biological products in the ICH region.
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!
Our e-learning, specially tailored for medical device advisors, provides you with the essential knowledge to navigate your professional duties confidently and in full legal compliance.
Our e-learning, specially tailored for medical device advisors, provides you with the essential knowledge to navigate your professional duties confidently and in full legal compliance.
Gain essential knowledge for your entry into the medical device industry in just 90 minutes! Understand regulations, market access, and vigilance with our compact e-learning.
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.
Are you involved in the planning and conduction of clinical trials with ATMP? Do you require current knowledge on the latest GCP guideline (ICH E6 (R3)) AND ATMP-specific considerations? Then join this seminar to stay informed (including training certificate)!
We will focus on how to integrate compliance and governance into Medical Affairs activities and ensure quality documentation that is both effective and pragmatic.
This online training offers comprehensive insights into Regulatory Affairs, CMC, and GMP requirements, with a focus on the latest updates and developments in EAEU countries.
This seminar provides newcomers and career changers with a comprehensive introduction to European and national medical device regulations. Participants gain essential knowledge on development, classification, clinical evaluation, and post-market surveillance of medical devices. Our preparatory e-learning ensures optimal readiness for the seminar and helps deepen the practical understanding.
Variation regulation, classification guideline, eSubmission, variation management: All processes explained in this online course.
This course offers a deep dive into patient involvement in HTA processes across Europe, with a focus on the UK and Germany - learn practical approaches, regulatory insights, and how to engage meaningfully with patient organisations.
Four live webcasts à 2 hours every week: CMC requirements in China, India, Japan, South Korea and Russia/EAEU. Meet our four experts to get an update on the current requirements in the different regions and discuss your individual issues with them. You are interested in one webcast only or a group account? Contact us!
This online-seminar will provide tips on how to prepare and maintain a core PSMF as well as annexes with the relevant local peculiarities worldwide. Register today!
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.
Are you a specialist in the pharmaceutical industry in the area of marketing authorization and responsible for compiling the quality documentation of active pharmaceutical ingredients (APIs) and their starting material? Then this is the right online seminar for you!
This online event offers a comprehensive overview of marketing authorisation and market access in the Middle East, covering key topics like market entry, intellectual property, lifecycle management, pharmacovigilance and quality considerations, with a focus on Gulf Cooperation Council, Saudi Arabia, the UAE, Jordan and Syria.
This seminar will focus on AMNOG and JCA dossier preparation as well as the German AMNOG procedure in comparison with the EU HTA procedure.
Non-clinical/clinical content in the dossier: Are you a beginner in the field and would like to feel confident working competently on modules 2, 4 and 5 in the future? Are you already an experienced specialist and would like to refresh, professionalise or "structure" your knowledge? Then you've come to the right place!
An interactive online seminar to explore real regulatory cases and challenges in marketing authorisation and lifecycle management across Mexico, Argentina, Colombia, Peru, Chile and Brazil - led by local experts from Brazil and Peru.
You as "beginner" or "refresher" would like to feel more secure writing CMC documents? Our experts will provide you with practical tips and tricks and share their experiences with you. After attending this virtual seminar you will be able to present data clearly and in compliance with the regulations.
Due to high demand - now available in English - Are you experienced in pharmacovigilance and looking for in-depth knowledge on managing a PV system and leading your team? Do you have specific questions about your role as responsible person? Then this online event is for you! Gain insights and expertise - from experts for experts.
You will gain actionable insights into global market access strategies, payer evidence requirements, and health economic tools - enabling you to support strategic decision-making across diverse healthcare systems.
Are you involved in the implementation and ongoing adaptation of the PV system? In this online course you will learn how to use the right Key Performance Indicators (KPIs) for your PV system in a profitable way. Reserve your seat now and be part of this insightful session!
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.
CMC dossier requirements FDA vs EU: After having attended the seminar you will feel secure writing and maintaining the quality dossier for US marketing authorisations of small and large molecules (chemicals and biologic).
Explore how recent U.S. pharmaceutical pricing reforms may impact the European pharma sector. This online seminar provides a transatlantic perspective on policy trends, trade risks, and pricing dynamics.
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. Take the next step in your professional growth - enrol 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!
This online conference covers EU regulatory developments, best practices for patient-centric labelling, digital transformation through ePI, and the latest innovations in labelling technology.
Get your know-how on creating and maintaining quality data for biotech products in our online training.
- Newly designed and engagingly structured - This application-oriented online seminar is designed for pharmacovigilance professionals responsible for drug safety projects or those actively involved in project teams. Learn practical project management skills and benefit from discussing case studies in pharmacovigilance step by step.
Do you want to strategically plan your early phase clinical trials (phase I/IIa) from the start to accelerate drug development? Then gain tips and hands-on experience in this online seminar!
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!
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.
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.
This online conference offers compact expert talks and diverse perspectives on global regulatory strategies, digital transformation and evidence generation. Expect focused insights, practical takeaways and lively discussions with experienced speakers - and stay informed about the latest developments in global regulatory practices.
This seminar provides an in-depth exploration of EU drug marketing authorisation, focusing on regulatory frameworks, application types and procedures. It covers mutual recognition, decentralised and centralised procedures (MRP, DCP, CP) in detail, providing essential insights for successful EU drug approval.
Experts from national authorities speak about the current developments with regard to e.g. the revision of guidelines (GACP, Variation Regulation, Variation Classification Guideline (current status)), the changes of procedures and corresponding chances (MRP/DCP), and the use/"impact" of new evaluation methods (Real World Data). The authority prespective is complemented by industry experience.
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.
Would you like to feel more confident presenting your CMC/quality data clearly and in full compliance with regulatory standards? Our two experts will share their extensive regulatory expertise in "advanced" CMC writing with you, providing you with real-world examples and practical tools.
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.
This online seminar provides a comprehensive introduction to drug market access and pricing strategies in five key European countries: Germany, Spain, the UK, Italy, and France. Designed for beginners and professionals seeking structured insights into HTA systems, stakeholder roles, and pricing negotiations.
Are you a QPPV, local Safety Officer, or part of a QPPV office within an international MAH? Looking for a targeted training course to improve your day-to-day activities and collaboration with other PV professionals? This seminar shows you how.
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, EU GMP Annex 11, New Annex 22 on AI, and an update on the ongoing discussions on nitrosamine "contaminations".
This two-day course equips beginners with the fundamentals of EU pharmacovigilance legislation, QPPV responsibilities, and strategic planning. Learn what it takes to fulfil the role, ensure compliance, and build your roadmap to QPPV readiness. Ideal for aspiring QPPVs or those preparing future candidates. Secure your place today!
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!
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!
