Series of EU Exit and Post Transition guidance webinars.
Due to high demand, we now have more spaces available for our upcoming EU Exit and Post Transition Guidance webinars.
From 1 January 2021, the Medicines and Healthcare products Regulatory Agency will be the UK’s standalone medicines and medical devices regulator.
Transition from the EU allows the UK to offer fully independent regulatory decisions for both devices and pharmaceuticals, both nationally and in joint work with other international regulators.
Stakeholders need to get ready for new rules from 1 January 2021. The agency has now published guidance which will apply following the end of the transition period, from 1 January 2021, and which will be developed further in due course.
To help stakeholders understand the detail of the guidance and to ask any questions, the agency is running a series of free webinars on important topics.
Monday 19 October 2020, 14:00-15:30
Guidance for manufacturers of biological medicines - independent batch release in the United Kingdom from 1 January 2021
(Held by The National Institute for Biological Standards and Controls)
This webinar will look at batches for the marketing in GB and Northern Ireland. The following topics will be discussed; sample submission, Lot release protocols, NIBSC certifications, marketing information forms, risk-based approach to independent testing, parallel testing and turnaround times.
Tuesday 20 October 2020, 14:00-15:30
UK supply chain regulation from 1 January 2021
This webinar will provide attendees with an in-depth understanding of the regulatory requirements UK medicines supply after 1 January 2021. Understand the implementation of published guidance and take the opportunity to ask questions relevant to your own products and supply chains.
Wednesday 21 October 2020, 10:00-11:30
This webinar will cover aspects of clinical trials that will apply from 1 January 2021. We will discuss applying for a CTA, trial registration and results reporting plus reporting of SUSARs. The webinar will also cover supply of IMP.
This webinar will cover the regulation of medical devices from 1 January 2021. We will discuss new registration and UK Responsible Person requirements, and provide an overview of the UKCA mark – which can be used on a voluntary basis from January 2021.
Thursday 22 October 2020, 10:00-11:30
Post EU Transition: Pharmacovigilance requirements for UK authorised products
This webinar will cover the revised regulatory framework for pharmacovigilance in the UK, the submission and assessment of pharmacovigilance data for UK authorised products, and requirements concerning the qualified person for pharmacovigilance (QPPV) and the pharmacovigilance system master file (PSMF).
Tuesday 27 October 2020, 10:00-11:30
UK marketing authorisation and variation procedures from January 2021
Review of MHRA guidance on new UK routes for marketing authorisation applications and variations, including applications containing new active substances, biosimilars and generic products and incentives for products intended to treat rare diseases. The session will also include information on variation submissions to MHRA from 1 January 2021.
Tuesday 27 October 2020, 14:00-15:30
Conversion of Community Authorisations to Great Britain MAs and handling of applications that are pending in the centralised and MRDC procedures at the end of Transition.
This webinar will cover how MHRA will handle conversion of Community Authorisations (MAs) to a Great Britain MA, pending Centralised Applications and approved and pending Mutual Recognition/Decentralised marketing authorisations on the 1 January 2021. The webinar will provide guidance on the options for a smooth transition and resolve any technical or procedural issues for a MA holder.
Wednesday 28 October 2020, 10:00-11:30
PLPI – the legal framework of parallel imports
A discussion on the legal framework for parallel imports from 1 January 2021.
Thursday 29 October 2020, 10:00-10:45
UK paediatric requirements from 1 January 2021
This webinar will explain the process for applicants applying for a UK Paediatric Investigation Plan (PIP), waiver, deferral, modification or compliance check from 1 January 2021. Paediatric requirements for UK Marketing Authorisation Holders will also be covered.
To keep up to date with new guidance and supporting events, visit Gov.UK or look out for announcements on our social media channels.