- Combination of three compulsory seminars plus one elective module for (future) Heads of the Pharmacovigilance Department - Learn the responsibilities and legal aspects of managing a PV system and its staff, and select an elective module according to your individual interests.
- Combination of three selected seminars - With this qualification course, you will first gain insight into the legal aspects and general responsibilities of the Qualified Person for Pharmacovigilance (QPPV). You will then deepen your professional and practical knowledge to perform your role more effectively.
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
With our modular qualification course, you can expand your competencies in drug regulatory affairs in a targeted and practice-oriented manner. You design your learning pathway individually and set professional focus areas in line with your occupational requirements. Including an overall certificate and up to 30% price advantage compared with individual bookings.
This e-Learning programme will provide you with knowledge on Good Distribution Practice in today's pharmaceutical industry
e-Learning in 5 modules: concept, data requirements and the AMNOG process up to the price negotiation
This e-Learning programme will familiarise you with the data requirements in CTD Module 3.
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.
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.
Stay informed with updates from our global and local experts, who will provide the latest regulatory and legislative insights every two months. In 2026, topics will include CMC documentation, regulatory intelligence, regulatory pathways in Africa, enrichment of PMS product data, global regulatory reliance models and ePI.
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.
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.
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.
- Registration possible until 17.02.26 - This two-day online course strengthens your skills in writing key pharmacovigilance safety documents. You will gain a clear understanding of regulatory requirements and hands-on experience in drafting and maintaining DSURs, PSURs and RMPs.
The European healthcare landscape is evolving - and so is the role of Medical Science Liaisons (MSLs). This one-day seminar provides an update on key regulatory changes, the growing impact of digital health and AI, and the increasing relevance of real-world evidence (RWE).
This seminar provides newcomers and career changers with a comprehensive introduction to European medical device regulation. 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.
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.
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 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.
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.
- Registration possible until 09.03.26 - 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!
Be fully prepared for the mandatory EUDAMED go-live from 28 May 2026. The seminar provides a practical overview of key regulatory requirements and how to translate them into an actionable plan across Regulatory, Quality and IT. The focus is on SRN readiness, UDI master data design, data quality for large portfolios and reliable procedures for registrations, updates and certificate data.
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.
CMC requirements in China, Japan, South Korea, India and Russia/EAEU. Meet our three experts to get an update on the current requirements in the different regions and discuss your individual issues with them. Contact us!
Are you wondering how to implement the quality requirements of GVP Module I in your organisation? Then this online seminar is just for you! After the training you will be able to monitor and optimise your PV system and you will be well prepared for the next inspection. Book your place now!
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.
Global regulatory requirements for drug device combination products (DDCs): You will receive a regulatory overview for the EU, the US, China, and MENA region, plus you will obtain tips and tricks by (local) experts on how to speed up the approval process.
This seminar provides an in-depth exploration of the marketing authorisation dossier and the electronic submission process, focusing on the CTD structure and Modules 1-5. Participants will gain practical knowledge and strategies for successful drug approval applications in the EU.
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.
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!
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).
Are you working in the QPPV Office or are you a Local Safety Officer? This focused online course supports your daily responsibilities and strengthens collaboration with national PV teams across the company. Using inspection readiness as a central theme, the training shows how global and local PV functions work together effectively. Register now!
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.
This course provides an overview of the regulatory framework and key requirements for planning, submitting and conducting clinical investigations of medical devices in the EU. It covers practical aspects from study preparation to close out, including documentation, monitoring, safety obligations and reporting requirements.
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 (single day = 1.290€ plus VAT) - for booking, please contact us!
This online webcast series provides a concise update on the EU Pharmaceutical Package. Across five two-hour modules, you learn about key regulatory changes, revised authorisation and protection rules, new obligations for managing shortages, and developments in environmental risk assessment. Gain practical guidance to adapt internal processes and responsibilities to the upcoming framework.
Gain a structured, practice-oriented overview of EU HTA, market access and pricing. The seminar covers the evolving EU pharma legislation, the interface between JCA and national HTA and country deep dives: UK & Ireland, Nordics, Germany, France and Italy,
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!
This course familiarises you with regulatory post-approval duties and provides first-hand information on variation submission, PV activities and labelling changes. It will also cover all important aspects of the revised variation framework (new Regulation and updated Guideline).
More than seven experts will provide you with in-depth knowledge on how to create the quality module in the registration dossier (focus on chemically defined products). These are your booking options: Day I+II (basic training): €1,990.00 (+ VAT), Day III (focus on ASMF & CEP): €1,290.00 (+ VAT), Days I-III (complete course): €2,690.00 (+ VAT)
Outsourcing of areas, tasks, or positions in pharmacovigilance is often standard practice. In this training course, you will not only gain the necessary knowledge to work with service providers but also learn in practice how to monitor them effectively and manage a robust quality system.
This seminar explores how artificial intelligence can be effectively and responsibly integrated into regulatory writing processes. You'll gain insights into legal requirements, learn about AI tools and technologies, and see how they apply to CTD documentation through practical examples and a live demonstration.
CMC changes: During the half-day training you will receive essential updates on new/revised (EMA) guidelines/papers focusing on Product Lifecycle Management (PLCM), Post Approval Change Management Protocol (PACMP) and stability testing.You'll benefit from the combination of regulatory authority perspectives and industry examples.
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.
This online two-day course equips new, aspiring, and practising QPPVs with a clear understanding of their role under EU pharmacovigilance legislation, focusing on key responsibilities, strategic planning, and effective oversight. Learn what it takes to perform the role in practice and ensure ongoing compliance.
This seminar shows Pharma teams how to use AI to create evidence-based content and strong cross-channel brand narratives. Through practical frameworks, real use cases and hands-on exercises, participants learn how to scale content efficiently while staying fully compliant. Ideal for marketers who want to apply AI safely and effectively in daily work.
Quality & GMP Essentials for Regulatory Affairs/CMC: Managing the interface - knowledge of quality-relevant facts, GMP fundamentals, as well as understanding of the processes at the interface - including an Update on various guideline revisions, e.g. ICH Q1, M4Q(R2) and more - Qualify now!
Enable teams to plan and run unbranded, non-promotional disease awareness campaigns that inform the public responsibly, remain clearly separate from product promotion, and are ready for EU-wide deployment.
This intensive seminar provides strategic insights into EU regulatory affairs. With updates on the new EU pharmaceutical legislation, you'll understand the regulatory framework for all important strategic decisions. Learn how to align your regulatory strategy with corporate goals, collaborate successfully with other departments & authorities, and use tools like RIMS effectively.
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!
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!
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.
The seminar covers essential topics such as stakeholder identification, effective meeting preparation, and legally compliant collaboration. Tailored for Medical Science Liaisons (MSLs) and Medical Affairs teams, the seminar equips you to gain real insights from KOLs, overcome challenging situations, and elevate patient outcomes.
Global variations and lifecycle management - covering key regions: USA, Asia (China, Japan, South Korea), LATAM (Central America, Brazil), and Gulf Cooperation Council (GCC). Take this opportunity to discuss your specific daily business challenges with our experts and network with peers to see how others approach similar issues!
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.
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.
Do you want to strategically plan your early phase clinical trials (phase I/IIa) from the start to accelerate drug development? Then get tips and hands-on experience regarding traditional and complex clinical studies in this online seminar!
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.
Boost your impact in European drug launches with this interactive Medical Affairs seminar on communication, cross-functional collaboration and launch excellence.
Variation regulation, classification guideline, eSubmission and variation management: All processes explained in this online course.
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).
This intensive two-day online course offers a concise yet comprehensive overview of all core elements of pharmacovigilance, including EU regulatory requirements and their practical implementation. It is ideal for professionals who need a clear, structured understanding of the full range of pharmacovigilance activities.
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.
EU GMP Revision: Are you prepared for the guideline changes in Chapter 4 (Documentation), Annex 11 (Computerised Systems), and Annex 22 (AI)? Receive your update - presented in a simple and understandable format - on the (expected) changes, as well as tips for practical implementation from our two experienced experts.
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.
CMC in transition: Successfully implementing guideline updates - what CMC managers need to know now! Benefit from the expertise of our two experts and plan strategically.
