Presentations for „Pharma / Medical devices“

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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 "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 01/07/-30/06/2023
online 01/08/-31/07/2023
online 01/09/-31/08/2023
online 01/01/-31/12/2023
online 01/02/-31/01/2024
online 01/03/-29/02/2024
online 01/04/-31/03/2024
online 01/05/-30/04/2024
online 01/06/-31/05/2024
online 01/08/-31/07/2024
online 01/09/-31/08/2024
online 01/10/-30/09/2024
online 01/11/-31/10/2024
online 01/12/-30/11/2024
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 and pharmacovigilance at your fingertips!

online
Your pre-meeting: Be prepared for your event

Attend one of our free pre-meetings to familiarise yourself with Zoom and the various ways in which you can interact during the event

online
PharmaFORUM Webcast Biologics "Regulatory Requirements for Combinations of Drugs and Devices"

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
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
PharmaFORUM Webcast International "Marketing authorization maintenance in LATAM"

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
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
PharmaFORUM Webcast Biologics "MINISTERIAL DECISION ON THE TRIPS AGREEMENT"

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 Writing

You would like to feel more secure writing CMC documents? Our experts will provide you with practical tipps 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 02/02/2023
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 06/02/2023
Generic Drugs: Market Access and Pricing in Europe

Online Seminar about Generic Drugs: Market Access and Pricing in Europe

online 07/02/2023
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 27/02/2023
Regulatory Affairs in the US

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

online 28/02/-01/03/2023
PharmaFORUM Webcast Biologics "Human antibodies - Case studies: What kind of supporting (non-)clinical data is required for CMC changes?"

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.

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PharmaFORUM Webcast International "Global CMC Strategy"

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
The Centralised Procedure - Marketing Authorisation of New Drugs

The centralised procedure step by step - scientific advice, CHMP opinion building and the European public assessment report.

online 10/03/2023
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 14-15/03/2023
Regulatory Affairs for Pharmaceuticals 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 21-22/03/2023
Multinational Clinical Trials of Medical Devices

Learn how to effectively organise multinational clinical trials for medical devices in the US, Europe and China in accordance with the international standard (ISO 14155).

online 22-23/03/2023
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 22/03/2023
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 23-24/03/2023
PRRC: The Person Responsible for Regulatory Compliance

This seminar focuses on providing attendees with a comprehensive understanding of the role and responsibilities of a PRRC (Person Responsible for Regulatory Compliance) in the medical device industry, including legal expectations and requirements, documentation, and handling issues related to communication with regulatory authorities and managing records.

online 27/03/2023
PharmaFORUM Webcast Biologics "Questions at the interface of CMC and non-clinics - how to contribute to successful non-clinical 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
Variations in Europe

Variation regulation, classification guideline, eSubmission, variation management: All processes explained in this online course. Save your place in our virtual zoom seminar room! The training course will be entirely held in English.

online 17-18/04/2023
Crash Course: Medical Device Regulation

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

online 18/04/2023
CMC requirements in Latin America

CMC requirements in Latin America with focus Mexico, Brazil, Colombia, Argentina, Chile, Peru and CAMCAR (Central America and Caribbean). The webcast format is comfortable to integrate into your daily work routine. You desire to choose only single webcast sessions? Contact us!

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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 24/04/2023
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 26-27/04/2023
Market Access & Pricing in Europe

Online seminar about Market Access & Pricing in Europe

online 27-28/04/2023
Digital International Healthcare Marketing

Digital International Healthcare Marketing - Get tips and hints from three long-term experienced experts for a successfull marketing strategy!

online 28/04/2023
PharmaFORUM Webcast Biologics "First-in-human (FIH) clinical trial applications and INDs for ATMPs: special considerations"

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 "Coordination of international maintenance activities - Variations Management globally"

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
Hot Topics Related to Quality in Herbal Medicinal Products

This conference focuses on the current quality guidelines and assessment criteria - authority's perspective and industry's experiences.

online 04/05/2023
Marketing Authorisation in the US with a focus on CMC

CMC requirements in the US: After having attended the seminar you will feel secure writing and maintaining the quality dossier for US marketing authorisations.

online 24/05/2023
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
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 07-12/06/2023
Pharmacovigilance Requirements in China - LATAM - EAEU - MENA

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

online 12-13/06/2023
PharmaFORUM Webcast International "Regulatory Affairs Maintenance in China - Annual Report"

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 "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.

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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.

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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
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
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
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
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: 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.

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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.

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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...).

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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.

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