Regulatory Opportunities in times of Covid-19 - Webinar Recording

Costs

*ECA-Member:**	EUR 199,--
*Regular Fee:**	EUR 249,--

(All prices excl. VAT). Important notes on sales tax.

Registration

* also payable by credit card

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@concept-heidelberg.de

Speakers

Dr Josef Hofer, EXDRA GmbH, Germany

Background

On 10 April 2020, the EMA, HMA and EC issued the first version of the “QUESTIONS AND ANSWERS ON REGULATORY EXPECTATIONS FOR MEDICINAL PRODUCTS FOR HUMAN USE DURING THE COVID-19 PANDEMIC” document in order to provide guidance to marketing authorisation holders (MAHs) on regulatory expectations and flexibility during the COVID-19 pandemic (latest revision issued on 17th April 2020). The “Practical guidance of the CMDh for facilitating the handling of processes during the COVID-19 crisis” is intended to give further explanations and practical guidance on how to address, apply and implement the provisions given by the Q&A document.

Target Group

This webinar is designed for all persons involved in the development, compilation and maintenance of pharmaceutical dossiers of medicinal products and will be of interest to personnel from Development, Quality and Regulatory Affairs.

Technical Details:

To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.

Timing and Duration:

When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.

In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.

Training Course Documentation and Certificate:

The presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation.

Programme

This webinar will give you a comprehensive overview of the information laid down in the Q&A document issued by the EMA, HMA and EC and the practical guidance issued by the CMDh. The handling of Marketing Authorisation procedures, sunset clauses, changes as well as renewals in times of Covid-19 will be discussed and explained.

Regulatory options and opportunities for medicinal products
Specific requirements, adaptations and interpretations
Regulatory tools and procedures
Practical guidance

Recording from 23June 2020

Duration of recording: 1,5 h.

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