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LEARNING SPACE
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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.
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.
5 consecutive webcasts - Pharmacovigilance in China, LATAM, EAEU, MENA, Latin America and on strategic questions
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.
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 and pharmacovigilance at your fingertips!
This course familiarises you with regulatory post-approval duties and provides first-hand information on variation submission, PV activities and labelling changes
The latest on EU digital programmes (PLM, SPOR, ePI, etc.) and implementation in your sector.
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.
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.
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 and pharmacovigilance at your fingertips!
Our MDSAP seminar provides a comprehensive introduction to the Medical Device Single Audit Program, including fundamentals, regulatory requirements in different countries, audit process, tools and preparation for MDSAP audits to improve the quality systems of medical device manufacturers and distributors.
This seminar covers scientific medical writing, including basics, effective writing, abstracts, literature searches, and improving English language skills. Gain valuable tools for communication and professional-level writing skills.
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.
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.
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.
This online course addresses the needs of regulatory affairs managers dealing with marketing authorisation in countries of the APAC region.
This online training provides you with in-depth knowledge on marketing authorisation, CMC and GMP requirements in (Non-)EAEU countries.
Learn the essentials of the MDR and how to navigate around the legislation and to apply it.
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 via Zoom.
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.
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 and pharmacovigilance at your fingertips!
To make the most of ICH Q12 opportunities you as a lifecycle manager 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 QbD.
Get your know-how on creating and maintaining quality data for biotech products in our online training.
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.
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 successfully resist on Chinese market for medical devices? Then attend our webcasts and learn more about the new Chinese regulation for medical devices, how to perfect your pre-market registration and post-market surveillance: Our local experts will provide you with brandnew information!
This seminar covers scientific medical writing, including basics, effective writing, abstracts, literature searches, and improving English language skills. Gain valuable tools for communication and professional-level writing skills.
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 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.
