Presentations for „Regulatory affairs & vigilance“

Further your education with our high-quality courses on regulatory affairs, pharmacovigilance and CMC. We provide excellent speakers and top-notch materials.

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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
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
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: 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
online 31/12/2024
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
Crash Course: Medical Device Regulation

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

online 22/01/2024
CMC Writing

You 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.

online 07/02/2024
Global variations and lifecycle management

Global variations & lifecycle management - regions covered: USA, Asia (China, Japan, South Korea), LATAM (Central America, Brazil), and GCC; take the chance and discuss your individual daily business challenges with our experts and your colleagues (How others do it!?)!

online
The EU Qualified Person for Pharmacovigilance (EU QPPV)

Update your knowledge: Our team of experts provides you with important and practical information about the tasks and responsibilities of an EU-QPPV.

online 21/02/2024
Regulatory Lifecycle Management

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

online 22/02/2024
The Pharmacovigilance System Master File (PSMF) in a Global Environment

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.

online 26/02/2024
FDA inspection readiness

FDA inspection readiness: Gain the knowledge and skills necessary to manage future FDA inspections with confidence and ease.

online 14/03/2024
Regulatory and GMP compliance in Eastern Europe

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

online 15-16/04/2024
Pharmacovigilance Inspection Readiness

Discover the cutting-edge landscape of (remote) pharmacovigilance inspection strategy in Europe through our dynamic online course. Acquire comprehensive knowledge about Good Pharmacovigilance Practice (GPvP), differences in GPvP inspections and about the wide spectrum of requirements across various countries. Save your place in our virtual seminar room.

online 22/04/2024
Pharmacovigilance Requirements in China - LATAM - EAEU - MENA

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 5 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!

online 10-11/06/2024
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 at your fingertips!

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: Common Technical Document and 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 and Procedures

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

online
online 31/12/2023