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Thursday 28th June 2018
Harmonisation and application of BCS-based Guidance
Royal Society of Chemistry, London
Purpose of the Meeting
This symposium will look at the progress of the ICH M9 guidance (Biopharmaceutics Classification System (BCS)-Based Biowaivers) from a regulatory and industrial perspective; evaluating barriers to implementation from a solubility, permeability and dissolution perspective. Attendees will also better understand the progress that has been achieved by the International Pharmaceutical Federation (FIP) initiative on biowaiver monographs for essential drugs. These monographs are in-depth literature reviews, assessing whether a biowaiver can be recommended for a new formulation of an active pharmaceutical ingredient (API) based on publicly available data. It is also the intention of the meeting to seek feedback from JPAG members via a panel discussion, which in turn can be fed back to the ICH M9 Expert Working Group as part of the public consultation process. In addition, the symposium will look to update delegates on progress in the related fields of clinically relevant dissolution specifications and outcomes from the IMI OrBiTo consortium.
Proposed outcomes
• Awareness of current requirements and future developments and challenges
• Opportunities to challenge / raise concerns and understand from experts in this field as to how they might be addressed
• Opportunities to provide their feedback into the ICH M9 process via an interactive panel discussion
• Hear from experts what is actually happening in practice and what the future state will look like.
Who should attend
This symposium should be attended by those involved in in vitro dissolution testing in R&D and production, in the compilation of regulatory dossiers and in the planning and execution of biowaivers in lieu of bioequivalence studies- particularly those working in consumer healthcare and developing markets. This symposium will also appeal to those working in CMOs and quality management.

Dr Andreas Abend - Merck
Dr James Butler - GlaxoSmithKline
Dr Nikoletta Fotaki - Bath University
Dr James Mann - AstraZeneca
Dr Mark McAllister - Pfizer


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SUBJECT: JPAG Symposium: Harmonisation and application of BCS-based Guidance / Thursday 28th June 2018 / Royal Society of Chemistry, London

TITLE OF EVENT: Harmonisation and application of BCS-based Guidance

DATE OF EVENT: Thursday 28th June 2018

EVENT LINK: www.jpag.org/102

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: www.jpag.org

SPONSORS: Royal Pharmaceutical Society and Royal Society of Chemistry

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

Dr Andreas Abend - Merck
Dr James Butler - GlaxoSmithKline
Dr Nikoletta Fotaki - Bath University
Dr James Mann - AstraZeneca
Dr Mark McAllister - Pfizer


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One of the better seminars I have attended (March 2018)

Very good vegetarian option for lunch, great venue! Very central and excellent organisation of the event (March 2018).

Good first experience of a JPAG symposium (February 2018)

Excellent programme, high-quality speakers, great variety; overall, highly valuable (February 2018)

Overall, learned a lot today, reinforcing my existing knowledge of cleaning validation (February 2018)

I thought the meeting was really excellent with informative presentations. The best meeting I have attended in a long time (May 2017)

As ever, JPAG delivers! (March 2017)

The day as a whole was thought-provoking and exceeded expectations, and has been very informative (March 2017)

Really good symposium with strong presentations and thought-provoking; lots to take away and consider (March 2017)

Well-organised and stimulating (February 2017)

Excellent programme of speakers and relevant topics (October 2016)

The JPAG seminars are very good but this time you have exceeded expectations; the selection of speakers, the presentations and focus on topics have been excellent (October 2016)

Excellent meeting covering a complex topic (QBD) thoroughly (June 2016)

Well organised, laid back in a good way; friendly, as usual (March 2016)

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Very well run meeting; posters and panel discussion very good addition to usual format; very authoritative speakers; nice variety of topics (March 2015)

I enjoyed it a lot! Very professional - I learnt a lot (December 2014)

Excellent symposium; good variation of speakers and content; enjoyable networking opportunity; best one I have attended; good interactive crowd re QP discretion (July 2014)

Expert presenters with well-illustrated presentations (May 2014)

A wide-ranging list of topics, good mix of different applications; thank you - very enjoyable and informative, great location (March 2014)

A friendly,informal group of scientists coordinated and attended this meeting - makes for an enjoyable experience (February 2014)

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Delegates at a symposium held at the Royal Society of Chemistry

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