Presentations for „Pharma / Medical devices“

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Your pre-meeting: Be prepared for your event

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

online
Qualification course: CMC-Specialist in Regulatory Affairs

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.

online
e-Learning: Market Access for Medical Devices in Germany

Our e-learning "Market Access for Medical Devices in Germany" gives you a comprehensive insight into the market access of medical devices in Germany. It consists of the two parts "Market Access for Medical Devices - The NUB Process" and "Reimbursement for the German Healthcare Market". Book both parts together here and receive a 20% discount compared to booking them individually.

online
PharmaFORUM Webcast Biologics "Filing for a BLA vs MAA application with focus on the CMC requirements"

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.

online
Pharmacovigilance Requirements in China - LATAM - EAEU - MENA

5 consecutive webcasts - Pharmacovigilance in China, LATAM, EAEU, MENA, Latin America and on strategic questions

online 12-13/06/2023
PharmaFORUM Webcast Biologics "Non-clinical aspects of RNA-based drug development"

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.

online
PharmaFORUM Webcast International "Regulatory Affairs Maintenance in China - Post approval change regulations update and management"

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!

online
Toxicology Summer School

During this summer school 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.

online 04-06/07/2023
Regulatory Lifecycle Management: Variations, Labelling and More

This course familiarises you with regulatory post-approval duties and provides first-hand information on variation submission, PV activities and labelling changes

online 06/07/2023
eSubmission Management in Europe

The latest on EU digital programmes (PLM, SPOR, ePI, etc.) and implementation in your sector.

online 11-12/07/2023
PharmaFORUM Webcast Biologics "MA in Brazil with a focus on 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.

online
PharmaFORUM Webcast Biologics "The new Clinical Trial Regulation and the Go-Live of Clinical Trial Information System (CTIS)"

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.

online
PharmaFORUM Webcast International "Regulatory Information Canada"

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!

online
Mastering the Medical Device Single Audit Program (MDSAP)

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.

online 06/09/2023
Scientific Medical Writing for Medical Devices

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.

online 07/09/2023
online 13/12/2023
Marketing Authorisation in Latin America

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.

online 18-19/09/2023
EU Regulatory Affairs introductory training course

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.

online 27-29/09/2023
PharmaFORUM Webcast Biologics "Advantages and disadvantages of different approval procedures (MRP/DCP/CP)"

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.

online
Marketing Authorisation in the APAC Region

This online course addresses the needs of regulatory affairs managers dealing with marketing authorisation in countries of the APAC region.

online
Regulatory and GMP compliance in Eastern Europe

This online training provides you with in-depth knowledge on marketing authorisation, CMC and GMP requirements in (Non-)EAEU countries.

online 10-11/10/2023
Crash Course: Medical Device Regulation

Learn the essentials of the MDR and how to navigate around the legislation and to apply it.

online 19/10/2023
CMC Management in Regulatory Affairs

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.

online 24-25/10/2023
PharmaFORUM Webcast Biologics "Hospital exemption in the initial application and regulatory context"

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.

online
PharmaFORUM Webcast International

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!

online
Integrated product development

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.

online 14/11/2023
CMC for Biologicals

Get your know-how on creating and maintaining quality data for biotech products in our online training.

online 16/11/2023
PharmaFORUM Webcast Biologics 2023

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.

online
CMC requirements in Latin America

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 05-06/12/2023
Masterclass China: Medical Device Marketing Authorisation for Advanced

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!

online 05-06/12/2023
Scientific Medical Writing for Medical Devices

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.

online 13/12/2023
online 07/09/2023
e-Learning: Medical Device Advisor (MPDG)

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!

online
e-Learning: Stability Testing in the ICH Region

This e-Learning programme will focus on stability testing for chemical and biological products in the ICH region.

online
e-Learning: CTD Module 3

This e-Learning programme will familiarise you with the data requirements in CTD Module 3.

online
e-Learning: Patient Engagement in Europe

e-Learning course with six modules on how to initiate and manage collaborations with patients and patient organisations successfully.

online
e-Learning: Reimbursement for the German Healthcare Market

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.

online
e-Learning: Market Access for Medical Devices - The NUB Process

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.

online
e-Learning: Common Technical Document & eCTD

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.

online
e-Learning: Introduction to EU Marketing Authorisation

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...).

online
e-Learning: EU Variation System & Procedures

This e-Learning programme will provide you with detailed knowledge on the classification, grouping and submission of variations in the EU.

online