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Presentations for „Regulatory affairs & vigilance“

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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 Biologics "CMC requirements for new excipients"

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
Online 01.11. - 31.10.2022
Online 01.12. - 30.11.2022
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
Marketing Authorisation in ASIA

Essential know-how on the current regulatory framework of the various countries will be addressed in this seminar.

Online 19. - 21.10.2021
ExpertFORUM Labelling

The annual labelling conference brings together authority and industry experts to address digital product information, structured data and safety labelling

Online 20. - 21.10.2021
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 26. - 27.10.2021
Supplier Management for Medical Devices

An up-to-date overview of and insights into supplier management for medical devices and related activities: Find the right balance between compliance, costs and quality, and learn how to implement your own effective vendor management.

Online 26.10.2021
PharmaFORUM Webcast Biologics "ICH Q12 - Current status"

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
Drug<->Device combination products: Taking hurdles efficiently

This training addresses the new regulatory framework for drug-device combination products. Use this opportunity to discuss the impact these changes will have on your products and how to implement the requirements. The training course will be entirely held in english.

Online 09. - 10.11.2021
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 11.11.2021
Marketing Authorisation in the Middle East

Marketing authorisation and market access in Saudi Arabia, the UAE, Jordan, Iran, Iraq and Turkey. If this is your business goal, don't miss out on this unique course! First-hand information provided by experienced speakers guarantees success.

Online 16. - 17.11.2021
Marketing Authorisation of Medical Devices in Saudi Arabia, the UAE and Jordan

Medical Devices: Marketing authorisation and market access in Saudi Arabia, the UAEand Jordan. Don't miss out on this unique course! First-hand information provided by experienced speakers to guarantee market success of your enterprise.

Online 18.11.2021
Writing for Medical Devices

The online course will show you how to write scientific and clinical documents such as a technical documentation or clinical evaluation in good and readable English that is appropriate to your audience, while complying with the regulatory requirements.

Online 25. - 26.11.2021
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: 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: 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
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
PharmaFORUM Webcast Biologics "The future of biosimilars without clinical phase 3 trials? Impact on CMC development strategy"

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 "PV and RA in India"

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
Market Access of Orphan Drugs

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

Online 21.01.2022
PharmaFORUM Webcast Biologics "Marketing authorisation in China: Focus on CMC ("Part I")"

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
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
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 17.02.2022
PV audits & inspection strategies - Day 1: Risk based PV audits

Our experts will help you to identify risks in your PV system and will provide you with helpful methods to adjust your audit processes and strategies. Save your place in our virtual seminar room.

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
PharmaFORUM Webcast Biologics "Impact of Covid-19 outbreak on future drug R&D"

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 Update China"

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
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
PharmaFORUM Webcast Biologics "Manufacturing site transfer"

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
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
PharmaFORUM Webcast Biologics "Marketing Authorisation in Japan with 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 International "Food supplements/over the counter drugs - export outside the EU area"

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 "Combination products and 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
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
PharmaFORUM Webcast Biologics "Digitalization/ Personalization of Healthcare"

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 "Marketing Authorisation of Drugs in Iraq/Iran"

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 "Lifecycle considerations for analytical methods"

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 "Regulatory support in pharmaceutical development - exchange with regulators from Bench to Bedside"

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 "A company's QPPV Network"

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 "Trends in preclinical studies on pharmacology/toxicology"

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 "Post-approval change management protocols"

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
Online 01.10. - 30.09.2022
Online 01.11. - 31.10.2022
Online 01.12. - 30.11.2022
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 01.12. - 30.11.2023
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

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