Pharsafer

The European Medicines Agency has published their latest questions and answers for stakeholders, regarding the implementation of Protocol on Ireland/Northern Ireland after the Brexit transition period; with key considerations for safety reporting, Eudravigilance, EudraCT, PSUR Repository, Product Information, GMP and manufacturing, parallel distribution and more.

For information:

www.ema.europa.eu

The European Medicines Agency will be holding a public meeting on 11th December 2020, regarding their involvement in the development and approval of vaccines, and accompanying EU regulatory processes; in addition to issuing a reminder for those wishing to speak in the meeting, to register their interest by 27th November 2020.

⬇ For more information: https://lnkd.in/ecanG62
⬇ To register to speak: https://lnkd.in/da5HSbH

EMA organises public meeting on COVID-19 vaccines - European Medicines Agency EMA organises public meeting on COVID-19 vaccines

MedDRA MSSO has issued a reminder, stating those wishing to submit change requests for MedDRA version 24.0 will need to do so before 1st December 2020; with any change requests submitted after this date to then be considered and processed for version 24.1.

⬇ To submit your change request: https://lnkd.in/eaRVRGT

⬇ For more information: https://lnkd.in/dWGQsYA

The European Medicines Agency issued their latest guidance, with key considerations for safety monitoring and risk management for vaccine safety and use in real life.

For more information:

COVID-19 vaccines: development, evaluation, approval and monitoring - European Medicines Agency COVID-19 vaccines: development, evaluation, approval and monitoring

The FDA has released their latest guidance for Enhancing Diversity Populations in Clinical Trials, with key considerations and recommendations for trial practises and designs, methodological approaches and improved enrolment and retention strategies.

For more information:

FDA Guidance for Enhancing Diversity Populations in Clinical Trials - PharSafer® - Specialists in Global Clinical and Post Marketing Drug Safety Summary of latest guidance released by the FDA, for Enhancing Diversity Populations in Clinical Trials, with key considerations.

Limited places available for next week's online course in Pharmacovigilance QMS & Inspection Preparation!

This 2 day online course will take place on 19th-20th November 2020 and will be led by our CEO Graeme Ladds and hosted by Management Forum Ltd; designed for industry professionals, working in both quality assurance and pharmacovigilance, and regulatory personnel; covering key subject areas such as regulatory expectations, for the pharmacovigilance QMS and risk-based audits, KPIs and management of the entire CAPA process.

⬇ To book now, visit: https://lnkd.in/dmYVJdw

Following the International Council for Harmonisation (ICH) E14/S7B Implementation Working Group recent meeting, where they revised existing guidance, looking at the in vitro updates for QT prolongation and human testing; ERT will be hosting a webinar on 12th November 2020, covering Q&As and providing a summary of key changes.

⬇ To register for the webinar:

BlueJeans Events | Attendee RegistrationApp

The FDA has established the Digital Health Center of Excellence, with the goal of promoting responsible and high-quality digital health innovation, through improving partnerships, sharing knowledge and modernising approaches to regulatory expectations for digital health technologies/medical devices.

For more information:

Digital Health Center of Excellence Information about CDRH's Digital Health Program

The Department of Health and Social Care has published updated guidance on the reporting requirements for medicine shortages and discontinuations.

⬇ For more information:

Reporting requirements for medicine shortages and discontinuations Guidelines to help mitigate and manage medicines shortages.

The Medicines and Healthcare products Regulatory Agency has recently updated their guidance, regarding the licensing of products after the end of the transition period, with updates made to guidance on new assessment routes; variations to and renewal of Marketing Authorisations (MAs); the conversion of Community Marketing Authorisations (CAPs) and more.

For more information:
⬇

MHRA post-transition period information Guidance for industry and organisations to follow from 1 January 2021.

The Medicines and Healthcare products Regulatory Agency has provided further guidance in relation to regulating the supply of medical devices after the end of the transition period.

For more information: https://lnkd.in/dM2RsyB

Regulating medical devices from 1 January 2021 What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets from 1 January 2021.

MedDRA MSSO will be hosting two open sessions for MedDRA users, on 27th & 28th October, covering a range of key subjects and questions; submitted by users in advance, regarding their use of MedDRA documentation and the tools provided by the MSSO.

To book your place, visit:

⬇ 27th - https://lnkd.in/dmWQsQw
⬇ 28th - https://lnkd.in/dkD9GMv