Webinar: Regulatory Opportunities in times of Covid-19
Course No 18103
Important: Deadline is 12 noon on 22 June 2020
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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 Requirements
For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings.
At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
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
GMP Conferences by Topics
- General Quality Assurance and GMP Compliance Topics
- Hygiene
- General Microbiology Topics
- Regulatory Affairs
- Development
- General Analytics Topics
- Good Distribution Practice
- Sterile Manufacturing
- Computer Validation
- General Qualification/Validation Topics
- General Engineering Topics
- APIs/Excipients
- GMP Basic Training Courses
- Medical Devices and Combination Products
- Packaging and Packaging Material
- Data Integrity
- Qualified Person (QP)
- GMP Auditing
- Documentation
- Cleaning Validation
- General IT Compliance Topics
- Impurities
- OOS / OOE / OOT
- Material Testing
- Validation of Analytical Methods
- Analytical Instrument Qualification
- Stability Testing
- Microbiological Testing
- Technology
- General Manufacturing Topics
- Solid Dosage Forms/Semi-Solid Dosage Forms
- Biotechnology/Blood/ATMP
- Herbal Drug Products/Cannabis/Radiopharmaceuticals
- Others