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Thursday 7th December 2023
Regulatory Hot Topics VIII
Royal Society of Chemistry, London

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This symposium will address an introduction to the issues and challenges associated with use of biowaivers. Additional topics will cover UK and international Recognition & Reliance regulatory procedures as well as updated, new and emerging ICH guidance from this year and a look forward into 2024.

This excellent opportunity for dialogue, discussion and debate with speakers and the peer group in an open forum where delegates will be able to understand, interpret and translate into day-to-day practice the guidance on our 2023 key topics:
- Biowaivers - background and case studies will be presented highlighting key differences in their use between countries
- British Pharmacopoeia topic updates from 2023
- Recognition & Reliance regulatory procedures - MHRA update on UK Recognition procedures and update around global reliance and/or accelerated processes
- ICH guidance news and updates from 2023 and looking forward into 2024 topics

This meeting encourages the potential for delegates to learn from expert speakers involved in the development of the guidance and best practice in challenging subject areas.

The event will be in-person only, at RSC, London.

Speakers:
Rabiea Abdullah - Consultant
Dr Leonard Both - MHRA
Neil Clayton - Pfizer
Peter Crowley - MHRA
Dr Helena Engman - AstraZeneca
Dr Lisa Hinchliffe - Regulatory CMC Consultant
Dr Adele Patterson - Bristol-Myers Squibb
Dr Melanie Pires - Senior Consultant, NDA Group
Priti Shah - AstraZeneca


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WANT TO PRESENT A POSTER?
There will be an opportunity to present posters on the broad subject area of the symposium, subject to acceptance of a submitted abstract.
Click here for details.


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and benefit from discounted prices.
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REGISTER NOW...
Delegate fees include registration, documentation, lunch and refreshments.


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DELEGATE RATES:
Concession : £ 45.00
Exhibitor SILVER : £ 850.00
Exhibitor-BRONZE : £ 700.00
Member : £ 195.00
Non-Member : £ 295.00
Student : £ 45.00


If you have any questions about the meeting, please contact us: events@jpag.org.




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SUBJECT: JPAG Symposium: Regulatory Hot Topics VIII / Thursday 7th December 2023 / Royal Society of Chemistry, London

TITLE OF EVENT: Regulatory Hot Topics VIII

DATE OF EVENT: Thursday 7th December 2023

EVENT LINK: https://www.jpag.org/168

VENUE: Royal Society of Chemistry, London
Burlington House, Piccadilly, London W1J 0BA

VENUE LINK: www.rsc.org/locations-contacts/

ORGANISED BY: Joint Pharmaceutical Analysis Group

WEB LINK: https://www.jpag.org/

SPONSORS: Royal Pharmaceutical Society and Royal Society of Chemistry

CONTACT: Hon Events Secretary JPAG, events@jpag.org


This symposium will address an introduction to the issues and challenges associated with use of biowaivers. Additional topics will cover UK and international Recognition & Reliance regulatory procedures as well as updated, new and emerging ICH guidance from this year and a look forward into 2024.

This excellent opportunity for dialogue, discussion and debate with speakers and the peer group in an open forum where delegates will be able to understand, interpret and translate into day-to-day practice the guidance on our 2023 key topics:
- Biowaivers - background and case studies will be presented highlighting key differences in their use between countries
- British Pharmacopoeia topic updates from 2023
- Recognition & Reliance regulatory procedures - MHRA update on UK Recognition procedures and update around global reliance and/or accelerated processes
- ICH guidance news and updates from 2023 and looking forward into 2024 topics

This meeting encourages the potential for delegates to learn from expert speakers involved in the development of the guidance and best practice in challenging subject areas.

The event will be in-person only, at RSC, London.

SPEAKERS:
Rabiea Abdullah - Consultant
Dr Leonard Both - MHRA
Neil Clayton - Pfizer
Peter Crowley - MHRA
Dr Helena Engman - AstraZeneca
Dr Lisa Hinchliffe - Regulatory CMC Consultant
Dr Adele Patterson - Bristol-Myers Squibb
Dr Melanie Pires - Senior Consultant, NDA Group
Priti Shah - AstraZeneca




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PAST EVENTS



We always seek feedback from delegates attending JPAG events through an Evaluation form.

A recent analysis of the results has shown that more than 95% of attendees thought that JPAG meetings were well planned, relevant and met their main objectives, and would recommend JPAG meetings to colleagues


TESTIMONIALS...

Very enjoyable and thought-provoking day; going away with plenty of notes and specific items for discussion.

Excellent meeting, challenging and thought provoking. The organisation was excellent, thanks to all the efforts that JPAG team have made.

I have not attended a bad JPAG meeting yet. They are really good value for money and I really love to get the presentations as PDFs


I did appreciate receiving the slides before, as then I could print them and make notes around them during the symposium.

Getting an industry perspective on this topic was most helpful.

I appreciate having access to relevant JPAG seminars from overseas; provision of lectures beforehand to allow reading beforehand.

I did like having the presentations available early, with the webinar portion being focused on Q&A.

Fantastic to hear from NHS speaker, provides real insight to patient/clinician considerations that we don't necessarily see in industry.

From attendee perspective, the course did not take up the whole day as no travel necessary and overall good value for money.

Hearing the information from the clinical setting side was very useful.

Well organized. This was an amazing session. Prior sharing of the presentation was a great add on!

The most useful aspect of the webinar was the variety in the presentations across industry and the regulators. Really good to review the presentations beforehand.

Good value, well organised symposium. Always useful for focused topics.

A very good day. Enjoyed getting to speak to the presenters to discuss current challenges in industry.

Well done to all the speakers and the organisers for being able to successfully hold highly informative conferences virtually! (July 2020)



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Delegates at a symposium held at the Royal Society of Chemistry





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