AGM Agenda
With Ian Jackson, MHRA Unit Manager Inspectorate Risk, Control and Governance & Process Licensing and Industry Experts
Agenda:
| 10:00 -10:30 | Welcome to AGM (see agenda above) Zoom guidance- Sarah Powell (10 minute break before start of MHRA meeting) |
Jane Smith (PQG Chairman) |
| 10:30 | Introduction to MHRA & Hot Topics Meeting Zoom breakout rooms – Sarah Powell |
Neil Wayman (PQG Vice Chairman) |
| 10:40 – 11:10 | ‘The Challenges of Extreme Cold Chain Supply’ | Stephan Croft (PQG) |
| 11:10 – 11:50 | Current hot topics, remote inspections and an update on the Innovative Licensing and Access Pathway (ILAP) | Ian Jackson (MHRA Unit Manager Inspectorate Risk, Control and Governance & Process Licensing) |
| 11:50 – 12:20 | Conducting remote audits of supply chains for both Investigational and Commercial products. | Dave Waddington (Director, NSF, & PQG) |
| 12:20 – 12:40 | Syndicate Exercise -delegates separate into groups to discuss one of the questions below. (This will be held in breakout rooms)
Q1 What could the MHRA do differently when conducting remote inspections to support auditees? |
Ian Jackson (MHRA), Neil Wayman (PQG Vice Chairman), Dave Waddington (NSF, & PQG), Stephan Croft (PQG), Romina Toppani (Quality Executive, GSK & PQG) |
| 12:40 – 13:00 | Panel Q&A | Ian Jackson (MHRA), Neil Wayman (PQG Vice Chairman), Dave Waddington (NSF, & PQG), Stephan Croft (PQG) |
| 13:00 | Thanks & Close | Neil Wayman (PQG Vice Chairman) |
On booking this meeting you will receive a confirmation of your place which may be used as a VAT receipt.
The day before the meeting (Monday 15th March), we will send you a link with instructions on how to join this meeting. Places for this event are available on a ‘first come, first served’ basis so please book your place as soon as you can. This is an exclusive event and the link to attend will only be sent to the person who books a place. We do ask you not to share the link, or any password given to you to.
We will send a CPD Certificate by email after the event. Please ensure the company name used for the booking is correct, as this will be used for your certificate.