BEGIN:VCALENDAR VERSION:2.0 PRODID:-//The Pharmaceutical Quality Group - ECPv6.3.5//NONSGML v1.0//EN CALSCALE:GREGORIAN METHOD:PUBLISH X-WR-CALNAME:The Pharmaceutical Quality Group X-ORIGINAL-URL:https://www.pqg.org/a X-WR-CALDESC:Events for The Pharmaceutical Quality Group REFRESH-INTERVAL;VALUE=DURATION:PT1H X-Robots-Tag:noindex X-PUBLISHED-TTL:PT1H BEGIN:VTIMEZONE TZID:Europe/London BEGIN:DAYLIGHT TZOFFSETFROM:+0000 TZOFFSETTO:+0100 TZNAME:BST DTSTART:20210328T010000 END:DAYLIGHT BEGIN:STANDARD TZOFFSETFROM:+0100 TZOFFSETTO:+0000 TZNAME:GMT DTSTART:20211031T010000 END:STANDARD END:VTIMEZONE BEGIN:VEVENT DTSTART;TZID=Europe/London:20210316T100000 DTEND;TZID=Europe/London:20210316T130000 DTSTAMP:20240328T211446 CREATED:20210201T145706Z LAST-MODIFIED:20210315T195704Z UID:9770-1615888800-1615899600@www.pqg.org SUMMARY:Hot Topics Meeting with the MHRA and Industry Experts - including a short 2021 PQG AGM DESCRIPTION:Tweet\nAGM -Virtual Meeting 10:00 am – 10:30 am – all members are welcome to attend\n(There is no charge for attending the AGM only)\nAGM Agenda \n\n10:00 am Opening of meeting by Chairman and Chairman’s report: Jane Smith\nFinancial report & Membership fee for coming year: Steve Moss\nPQG Developments and Committee changes:  Jane Smith\n10:30 am Meeting closes\n\nHot Topics meeting 10:40 am – 1:00 pm\nWith Ian Jackson\, MHRA Unit Manager Inspectorate Risk\, Control and Governance & Process Licensing and Industry Experts \n  \nAgenda: \n\n\n\n10:00 -10:30\nWelcome to AGM (see agenda above)\nZoom guidance- Sarah Powell\n(10 minute break before start of MHRA meeting)\nJane Smith (PQG Chairman)\n\n\n10:30\nIntroduction to MHRA & Hot Topics Meeting\nZoom breakout rooms – Sarah Powell\nNeil Wayman (PQG Vice Chairman)\n\n\n10:40 – 11:10\n‘The Challenges of Extreme Cold Chain Supply’\nStephan Croft (PQG)\n\n\n11:10 – 11:50\nCurrent hot topics\, remote inspections and an update on the Innovative Licensing and Access Pathway (ILAP)\nIan Jackson (MHRA Unit Manager Inspectorate Risk\, Control and Governance & Process Licensing)\n\n\n11:50 – 12:20\nConducting remote audits of supply chains for both Investigational and Commercial products.\nDave Waddington (Director\, NSF\, & PQG)\n\n\n12:20 – 12:40\nSyndicate Exercise -delegates separate into groups to discuss one of the  questions below.  (This will be held in breakout rooms) \nQ1 What could the MHRA do differently when conducting remote inspections to support auditees?\nQ2 What could industry do differently to support external inspection to facilitate the auditor/inspector?\nIan Jackson (MHRA)\, Neil Wayman (PQG Vice Chairman)\, Dave Waddington (NSF\, & PQG)\, Stephan Croft (PQG)\, Romina Toppani (Quality Executive\, GSK & PQG)\n\n\n12:40 – 13:00\nPanel Q&A\nIan Jackson (MHRA)\, Neil Wayman (PQG Vice Chairman)\, Dave Waddington (NSF\, & PQG)\, Stephan Croft (PQG)\n\n\n13:00\nThanks & Close\nNeil Wayman (PQG Vice Chairman)\n\n\n\nOn booking this meeting you will receive a confirmation of your place which may be used as a VAT receipt. \nThe 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. \nWe 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. \n  \n  \n  \n\nTweet URL:https://www.pqg.org/a/event/pqg-agm-2021-and-hot-topics-meeting/ END:VEVENT END:VCALENDAR