With just over 3 weeks to go until the EPiC Autumn Compliance Seminar on Thursday 10th November 2022 we have released a copy of the whole day’s agenda.
Here’s a summary of what is covered:
- Guest speaker Richard Parker, Senior GMDP Inspector at the MHRA will be delivering an MHRA update on Annex 1 with a regulators view of the changes.
- Richard Andrews (EPiC & ex MHRA GMP Inspector & Unit Manager) will be your host for the day as well as giving an overview of recent updates to guidance & regulations and how to future proof your compliance.
- Michelle Yeomans (EPiC Operations Manager and ex MHRA GMDP Inspectorate Unit Manager) will be reviewing the direction of travel for compliance and speaking to Louise Mawer (ex MHRA Inspector) about the implementation of the Clinical Trials Regulation and overcoming challenges at the IMP/GCP interface.
- Darren Jones (EPiC & ex MHRA Inspector) will explain how to develop your PQS and move from remediation to sustainable compliance, as well as discussing current and future Annex 1 deficiencies and the the pitfall to avoid.
- Liz Allanson (EPiC & ex MHRA GMP Inspector) will give a presentation on points to consider when moving from an R&D to a GMP environment.
- Guest speakers Gaynor Brummitt (SeerPharma UK & ex MHRA Senior GDP Inspector) & Shahbaz Sarwar (SeerPharma UK ex MHRA GDP Inspector) will be explaining Importation and the Role of the RPi.
- There will also be a Q&A session where a panel drawn from the speakers will answer questions submitted throughout the event.
Download the Agenda here:
The day promises to be of real interest to pharmaceutical industry professionals involved in the manufacture and supply of medicines and aims to;
- Share recent changes and updates to the GMP and GDP Guidelines and Regulations with particular focus on Annex 1.
- Highlight changes to inspection practices and MHRA oversight.
- Discuss tools and practices to maintain compliance.
- Present current and future Annex 1 deficiencies, along with the pitfalls to avoid.
- Provide insight into the changes arising from the implementation of the Clinical Trials Regulations and points to consider around the IMP / GCP Interface.
- Explore the challenges and considerations when moving from an R & D to a GMP Environment.
How to secure your place
Tickets are now available to buy online and cost £250.00 + VAT
Click on the button below to register
In collaboration with SeerPharma UK
You may also be interested in the SeerPharma UK GDP Symposium taking place on Tuesday 8th November 2022: Register and Pay Online Here