Events

Monday, 12 March 2018:
EU GMP ANNEX 1 DRAFT REVISION INSIGHT Joint PHSS & PQG Conference – Discussion

Venue: Woodland Grange, Leamington Spa

Location: Old Milverton Lane, Leamington Spa CV32 6RN

Meeting begins: 10:00 am ending at 16:30

Cost: PQG members £250 + vat (£300) Non-members £350 + vat (£420)

BOOKINGS

Bookings will be via the PHSS website.  If you are a PQG member please email Sarah at admin@pqg.org. I will send you a code and a link (within 24 hours) which will allow you to book at the discounted rate of £250 + VAT.

Following the revision of EU GMP Annex 1 for Sterile Medicinal product manufacturing the PHSS: Pharmaceutical & Healthcare Society and PQG: Pharmaceutical Quality Group are joining together to host a discussion on the revision with the regulatory authorities.

The revision of Annex 1 will impact all in sterile medicinal product manufacturing and those sectors where Annex 1 applies: Advanced therapies and Hospital pharmacy aseptic services.

Comments from both PHSS and the PQG Annex 1 focus groups will be collated and submitted to the EMA.

The MHRA are invited to join the discussion with the PHSS & PQG on the impact of the Annex 1 revision and discuss focus group comments that are in preparation for submission to the EMA.

The Conference will also host exhibitors that have technologies and services that support sterile and therapeutic product manufacturing and aseptic processing.

Limited places available, both PHSS and PQG members can book at the discounted price of £250 + VAT.

AGENDA

Key note presentation: Regulatory perspective on EU GMP Annex 1 consultation document.

10.00am – 11.00am: Andrew Hopkins MHRA GDMP Expert: Head of EU GMP Annex 1 EMA/PICS/WHO revision working group.

Presentation: Pharma industry perspective on EU GMP Annex 1 consultation document.

11.00am – 12.00pm: Ian Symonds GSK Head, Aseptic Strategy and Intelligence, Pharma Ops, Global Function representing the PHSS & PQG Annex 1 Focus group preparing comments from the Pharma Industry on the revised Annex 1 draft/ consultation document.

12.15pm – 12.45pm: Overview-listing of PHSS-PQG Comments to be submitted to the EMA presented by discussion facilitators covering each of the Annex 1 chapters providing an insight to the type and extent of PHSS-PQG comments.

12.45pm – 2.00pm: Lunch break / viewing exhibition / networking

2.00pm – 3.15pm: Discussion Session 1.

Facilitators Neil Wayman: AstraZeneca UK, Chairman of PQG: Pharmaceutical Quality Group and Una Hearty Pfizer Ireland: representing the PHSS Annex 1 focus group. Discussion format:

  • Discussion on prepared/ selected questions on key concerns and comments on Annex 1 revision. Facilitators will introduce the questions with background information and open up discussion to the conference audience.
  • Discussion with open questions from the conference audience with responses from the MHRA and Pharma Industry representing the PHSS Annex 1 focus group.

3.15pm – 4.30pm: Discussion Session 2.

Facilitators Mike Davies: GSK UK Director, Aseptic Strategy & Intelligence Pharma Ops Global Functions, Co-leader of PHSS Aseptic processing and Bio-contamination special interest group & member of PHSS Annex 1 focus group.

James Drinkwater: Chairman of PHSS, F Ziel GmbH Head of GMP Compliance, Co-leader of PHSS Aseptic processing and Bio-contamination special interest group & PHSS Annex 1 focus group and member of PQG.

  • Discussion on prepared/ selected questions on key concerns and comments on Annex 1 revision. Facilitators will introduce the questions with background information and open up discussion to the conference audience.
  • Discussion with open questions from the conference audience with responses from the MHRA and Pharma Industry representing the PHSS Annex 1 focus group.

Conference Close & Thanks 4.30pm: PHSS & PQG Chairman

http://phss.co.uk/


Tuesday, 20 March 2018:
The PQG Annual General Meeting (PQG Members only)

The PQG Annual General Meeting (PQG Members only)

Date: Tuesday 20th March 2018

Venue: NEW VENUE Pullman Hotel, 100 – 110 Euston Road, London,NW1 2AJ Click here for location and directions to the Pullman Hotel

Meeting begins: This meeting will begin at approx 9:30 and end by 10:45.

Directions from Kings Cross St Pancras  follow the British Library exit signs, turn right onto Euston Road. Walk for 300m past the British Library, the hotel is located 5m on the right.

Directions from  Euston Station turn left on Euston Road at the Fire station and follow Euston Road for 600m. The hotel is on your left after Chalton Street.

PQG members do not need to book for this part of the meeting.


Tuesday, 20 March 2018:
The 21st Annual Discussion Meeting with the MHRA for QPs, QA Managers and their colleagues (open to Non Members)

The cost of the meeting is:

£180.00 (£150.00 + £30.00 VAT) for PQG Members
£225.00 (£187.50 + £37.50 VAT) for non-members

Date: Tuesday 20th March 2018

Location: NEW VENUE Pullman Hotel, 100-110 Euston Road, London, NW1 2AJ Click here for location and directions to the Pullman Hotel

Meeting begins: This meeting will begin at approx 11:00 and end by 16:30.

We would like to focus on subjects of particular relevance from the past year. There will be table discussions on case studies, followed by feedback from the Inspectors. Further details will be available soon. There will still be the usual Q&A session, so please submit your questions as soon as you can.

Questions: As in previous years, questions on any aspects of GMP from the audience will be discussed openly.

We are again asking attendees to submit questions to admin@pqg.org well in advance to allow sufficient time for MHRA to review and collate responses. Consequently, we will take questions from now until 28th February 2018. After that questions can only be asked if there is time on the day.

To book your place and pay by Credit Card, click on the green button above in this advert.

Early booking is advised: As this is a very popular meeting, early booking is advisable.

To facilitate participation and open discussion, numbers will be strictly limited to 50 attendees.

To contact the meeting organiser: e-mail admin@pqg.org

Confirmation of your place and VAT receipt: You will receive this by e-mail within a week of booking your place. A certificate of attendance will be provided at the meeting for your CPD records.


Thursday, 19 April 2018:
Good Distribution Practice (GDP): Meeting the challenges

The cost of the meeting is:

£180.00 (£150.00 + £30.00 VAT) for PQG Members
£225.00 (£187.50 + £37.50 VAT) for non-members

Date: Thursday 19th April 2018

Venue: Pullman Hotel, 100 – 110 Euston Road, London,NW1 2AJ Click here for location and directions to the Pullman Hotel

Meeting begins: This meeting will begin at 9:30 and end by 16:00.

Directions from Kings Cross St Pancras  follow the British Library exit signs, turn right onto Euston Road. Walk for 300m past the British Library, the hotel is located 5m on the right.

Directions from  Euston Station turn left on Euston Road at the Fire station and follow Euston Road for 600m. The hotel is on your left after Chalton Street.

Good Distribution Practice is essential to ensuring that the quality of medicines is maintained all the way through the supply chain.This event will help you to meet the challenges of complying with GDP with a team of highly experienced Responsible Persons and input from MHRA.

Each participant will be able to attend two of three workshops focussed on topics where regulatory inspections findings are most commonly made.  These workshops will be led by Ciaran Brady (PLS Pharma), Ashley McCraight (Ashley McCraight Associates) and Sue Mann (Sue Mann Consultancy) with Afshin Hosseiny (Tabriz Consulting and Chair of European GDP Association).

All attendees will also be provided with a copy of the new GDP monograph developed jointly by PQG and the European Compliance Academy.

The proposed agenda is given below (this may be subject to change)

9:30 Chairman’s Introduction (Ashley McCraight)
09:40 GDP Interpretation document – history, development, final version & thank you!  (Phil Butson)
10:00 MHRA Presentation (Tony Orme)
10:45 Q&A
11:00 Coffee/tea break
11:30 Workshops (1 – QMS, 2 – Transportation, 3 – RP – roles & responsibilities)
12:30 Lunch
13:30 Workshops (1 – QMS, 2 – Transportation, 3 – RP – roles & responsibilities)
14:30  Coffee/tea break
14:45 How to achieve compliance without interrupting business activities (Afshin Hosseiny)
15:30 Panel Discussion with Team leaders & MHRA
16:00  Final words from chairman & End of the course

To book your place and pay by Credit Card, click on the green button above in this advert.

To contact the meeting organiser: e-mail admin@pqg.org

Confirmation of your place and VAT receipt: You will receive this by e-mail within a week of booking your place. A certificate of attendance will be provided at the meeting for your CPD records.


NOTE: PQG payments and refunds policy for meetings.

Payment must be made prior to the meeting using our Credit card payment system. In case of difficulty paying this way, please contact the meeting organiser using the e-mail contact listed for each meeting.

Entry to events may be refused if payment is not received before the event.
Refunds for non-attendance will only be given if notified to the meeting organiser more than 14 days before the event. Once payment has been made, cancellations will incur an administration fee, which will be a minimum of £25.
Substitutions may be made at any time, preferably in writing to the meeting organiser shown on the meeting notice above.

Note that the PQG reserves the right to alter any meeting programme in the event of unforeseen circumstances.

At any meeting, the views expressed by individual contributors are their own and may not necessarily reflect the views of PQG as a whole.