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.
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 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 seminar 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!
Here you will get the latest information on the process of joint clinical assessments, including scoping and JCA dossier preparation.
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. Reserve your seat in our virtual seminar room.
Participants in this qualification course will receive thorough training on the main regulatory duties, from marketing authorisation applications to lifecycle management. This is the ideal preparation for starting a career in drug regulatory affairs. After course completion a certificate will be awarded.
Pharmaceutical industry in transition: The importance of AI for quality & efficiency - Artificial Intelligenge in GxP-/ISO-regulated areas.
The conference will cover recent updates and practical implications of the EU pharmaceutical legislation, management of supply shortages, and the new EU Variation regulation. Additionally, it will address the latest developments in quality guidelines, impurities (with a focus on nitrosamines), and the application of AI in CMC and quality processes.
Project management in GxP - Managing projects successfully and efficiently in a regulated environment!
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.
Attend this seminar to gain in-depth knowledge of the CCDS concept, global labelling requirements, and practical insights into market-specific regulations in the EU and USA.
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!
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 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.
Enhance your skills in writing key pharmacovigilance safety documents. In this two-day online seminar, you will gain a comprehensive understanding of the regulatory requirements and hands-on experience in crafting and maintaining PSUR, RMP, and DSUR. Learn best practices, avoid common pitfalls, and address global challenges to become a proficient "Pharmacovigilance Writer"!
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 face-to-face 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.
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 course familiarises you with regulatory post-approval duties and provides first-hand information on variation submission, PV activities and labelling changes.
This online course offers an in-depth overview of the medical device approval process in key global markets: Regulatory strategies, approval steps and timelines for global market access, with a focus on North and South America, the Asia-Pacific region and China.
The Good Pharmacovigilance Practices modules (GVP modules) by the European Medicines Agency (EMA) serve as a reference for standard practices in pharmacovigilance. This online course serves as a refresher and ensures that you are up to date with the best practices.
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.
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!
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!
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!
Experts from national competent authorities speak about the current developments with regard to e.g. the revision of guidelines (GACP, Variation Regulation, Variation Classification Guideline), the changes of procedures and corresponding chances (MRP/DCP), and the use and "impact" of new evaluation methods (Real World Data). The authority's prespective is complemented by industry's experiences.
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 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.
