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Presentations for „Online-Training“

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Global Regulatory Affairs Manager

This online training addresses the needs of regulatory affairs managers dealing with marketing authorisations outside the EU or planning to do so in the future.

Modular e-Learning and webcast Access possible at any time
Modular e-Learning and webcast Access possible at any time
PharmaFORUM Webcast Clinical Trials

Our experts will update you every month with the latest updates and trends in clinical studies. Thus, you will always have essential information on the ragulatory framework, on the design and conduct of clinical trials, as well as practical tips for successful collaboration at the interfaces to other areas.

Online
Online 01.11. - 31.10.2022
Online 01.01. - 31.12.2022
Online 01.02. - 31.01.2023
Online 01.03. - 28.02.2023
Online 01.04. - 31.03.2023
Online 01.05. - 30.04.2023
Online 01.06. - 31.05.2023
Online 01.07. - 30.06.2023
Online 01.08. - 31.07.2023
Online 01.09. - 31.08.2023
Online 01.10. - 30.09.2023
Online 01.11. - 31.10.2023
Online 01.12. - 30.11.2023
PharmaFORUM Webcast Biologics

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
Clinical trials in a nutshell: The European regulatory framework

All the essentials of clinical trials in Europe in only two days! Six experts will share their in-depth knowledge with you to introduce you as beginner or update you as professional on the most important aspects. Pose your individual questions in advance or live to make the most of your training!

Online 02. - 03.12.2021
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 07. - 08.12.2021
eSubmission Management in Europe

The course provides practical, hands-on experience in eCTD specifications, eSubmission requirements and data integrity for IDMP, SPOR and XEVMPD. Save your place in our virtual zoom seminar room.

Online 08. - 09.12.2021
eCTD preparation and submission

This online training programme consisting of three recorded webcasts will train you how to develop documents, compile them and submit an eCTD step by step.

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
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: Marketing Authorisation Outside the ICH Region

This e-learning will familiarise you with the regulatory affairs principles outside the ICH region and show you how to categorise the various regions in terms of regulatory requirements. Dossier requirements in Australia, Hong Kong, India, South Korea, Taiwan, Saudi Arabia, GCC, Jordan, Turkey, Thailand, China, South Africa, Russia, Kazakhstan, Eqypt, Brazil, Mexico & Argentina will be addressed

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
Pharmacovigilance in Europe - Introductory e-Learning

Do you need to be well versed in European pharmacovigilance for your daily work? Then we recommend this e-Learning. You can choose between three different packages according to your level of expertise and requirements.

Online
Market Access of Orphan Drugs

Evidence generation, value proposition and the HTA - the latest insights with regard to Orphan Drugs

Online 21.01.2022
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 07. - 08.02.2022
Regulatory Affairs in the US

Meet the expert Dr. Ulrich Granzer and get first-hand information, hints and tips for your daily business challenges with FDA approval of a medicine for the US market!

Online 08. - 09.02.2022
IDMP - what you need to do NOW

This workshop helps you collect, clean and structure all necessary data for IDMP and informs you on ePI (structured electronic product information) - a digitalisation project potentially utilizing IDMP and SPOR

Online 17.02.2022
PV audits & inspection strategies - Day 2: Pharmacovigilance Inspection Readiness

Our online course will provide insights into the current (remote) pharmacovigilance inspection strategy in Europe. Learn all you need to know about the differences in the inspections and about the different requirements in this training. Save your place in our virtual seminar room.

Online 18.02.2022
Generic Market Access & Pricing in Europe

Online Seminar about Generic Market Access & Pricing in Europe

Online 22.02.2022
Expanded Access Programmes

Compassionate Use Programme (CUP) and Named Patient Programme (NPP) - the expertise required to plan and conduct expanded access programmes.

Online 23.02.2022
PharmaFORUM Webcast Clinical Trials "The use of Immersive Medical Simulation as an innovative tool in clinical research"

Our experts will update you every month with the latest updates and trends in clinical studies. Thus, you will always have essential information on the ragulatory framework, on the design and conduct of clinical trials, as well as practical tips for successful collaboration at the interfaces to other areas.

Online
Regulatory Affairs China and ASEAN CTD

Three experts will give you an in-depth update on your duties with regard to accepted clinical trial data, dossier submission and the post-approval processes in CHINA. Including the latest eCTD specifications of TAIWAN.

Online 22. - 23.03.2022
The Person Responsible for Regulatory Compliance

How to prepare effectively for the responsibilities of a person responsible for regulatory compliance (PRRC). This and more in our online-seminar via Zoom!

Online 22.03.2022
RMP and PSUR in life-cycle management: An art, not a miracle

Tips & tricks for managing periodic reports and risk management plans post marketing authorisation. Furthermore insights into global PV document management will be given. Thus the training course gives you an allround overview.

Online 23.03.2022
Regulatory Affairs in Japan

Here you will get useful information for your marketing authorisation and the CMC requirements in Japan. It includs also abridged procedures and cultural considerations

Online 05. - 06.04.2022
Vendor Oversight in the Pharma Industry

Effective oversight of outsourced activities in the healthcare sector - Prepare yourself for the balancing act between compliance and outsourcing, and learn how to implement your own effective regulatory vendor oversight programme. Save your place today.

Online 05. - 06.04.2022
Regulatory Affairs, CMC and GMP in Russia

This online training provides you with in-depth knowledge on marketing authorisation, CMC and GMP requirements in Russia, Belarus, Kazakhstan and Ukraine. These are your booking options: Day I+II (basic training course): € 1.690,00 (+ German VAT), Day III (focus GMP, course may be booked separately): € 1.090 (+ German VAT), Day I-III: € 2.480,00 (+ German VAT)

Online 26. - 28.04.2022
Online 11. - 13.10.2022
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
Medical Writing in Pharmacovigilance

This two-day course provides an introduction to medical writing for pharmacovigilance, as well as insights into several relevant safety documents.

Online 22. - 23.06.2022
Pharmacovigilance Requirements in Emerging Markets

The diversity of PV-relevant regulations defining the art of good PV practice call for a finely tuned balance to ensure that all PV systems employed by a company tie into a unified and truly global PV matrix. Our experts in this course will give you a detailed update on the current legal and regulatory background and on your duties.

Online 27. - 28.06.2022
Regulatory Affairs, CMC and GMP in Russia

This online training provides you with in-depth knowledge on marketing authorisation, CMC and GMP requirements in Russia, Belarus, Kazakhstan and Ukraine. These are your booking options: Day I+II (basic training course): € 1.690,00 (+ German VAT), Day III (focus GMP, course may be booked separately): € 1.090 (+ German VAT), Day I-III: € 2.480,00 (+ German VAT)

Online 11. - 13.10.2022
Online 26. - 28.04.2022
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 Clinical Trials

Our experts will update you every month with the latest updates and trends in clinical studies. Thus, you will always have essential information on the ragulatory framework, on the design and conduct of clinical trials, as well as practical tips for successful collaboration at the interfaces to other areas.

Online
PharmaFORUM Webcast Biologics

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
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