Exploratory Medicines Development: Innovation And Risk Management, London, May 2017 – registration open

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Registration for the EUFEMED 2017 conference – Exploratory Medicines Development: Innovation And Risk Management has now opened.

Members of AHPPI get substantial savings on the non-member prices ranging from £37 (early-bird workshop only) to £103.20 (early-bird workshop and conference) when including VAT.

  • Pre-conference workshop, 17 May – link
  • Conference programme – link
  • Registration page – link

The pre-conference workshop will be followed by a welcome reception and opportunity to register for the conference itself, even if you don’t attend the workshop.

The conference dinner will be at the Museum of London.

A sponsorship and exhibitor pack will be available soon.

Hope to meet you there!

The AHPPI Committee.

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EUFEMED Clinical Pharmacology Conference, London, May 2017 – Web site goes live!

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Letter from the President:

Dear Colleague,

On behalf of the Organising and Scientific Committees it is our great pleasure to welcome you to the 1st conference of the European Federation for Exploratory Medicines Development (EUFEMED), to be held from May 18 – 19, 2017 in London, United Kingdom.

This conference is the result of a continued joint effort of the founding associations of EUFEMED: BAPU (Belgium), Club Phase 1 (France), AGAH (Germany) and AHPPI (United Kingdom). Indeed, after organising successful joint meetings in Berlin (2011), Nice (2013) and Brussels (2015) we are proud to present to you this exciting scientific program.

Following the tradition of previous conferences, this 2-day meeting provides an excellent opportunity to hear about recent advances in early clinical drug development. To that end a mixture is offered of focused scientific sessions, interactive workshops and open forum panel discussions. Being aware of the importance of safety in exploratory medicines development, the focus of the 2017 meeting is on innovation and risk management in early phase clinical trials.

A 1-day preconference workshop takes place on 17 May and is dedicated to practical aspects of assessing and mitigating risk in early clinical drug development.

It is our intention to offer a stimulating scientific atmosphere in which you can meet old colleagues and make new friends, inspired by the lively city of London.

We welcome you to EUFEMED 2017!

Conference Website

 

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Revising the guideline on first-in-human clinical trials

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The EMA yesterday published a guideline:

Draft guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products

The document can be found here.

The consultation period ends 28-Feb-2017.

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Exploratory medicines development – Innovation and risk management

First EUFEMED Conference

Joint Meeting of European Human Pharmacological Societies
Wednesday 17 May – Friday 19 May, 2017, London/UK


Assessment and mitigation of risk are most challenging in exploratory drug development when a promising new compound is to be characterised in early phase clinical trials.

  • How can we make best use of the results from nonclinical studies to better predict the risk in healthy subjects and volunteer patients?
  • How can combined protocols safely and successfully include healthy volunteers and patients in one trial?
  • Can assessment of target engagement via PD markers help to minimise risk in early development?
  • Is physiology-based PK useful to mitigate risk?
  • How do risks differ between biologicals and small molecules?

These and related topics will be addressed by the first conference of the European Federation for Exploratory Medicines Development (EUFEMED) focusing on

Exploratory medicines development – Innovation and risk management

In the tradition of previous Joint Meetings, AHPPI, the AGAH (Germany), Club Phase 1 (France) and BAPU (Belgium) have again connected to present you with state-of-art lectures and break-out groups discussing hands-on solutions.

The conference will take place in the Royal Borough of Kensington and Chelsea at the Kensington Conference Centre.

Details will be available on our website soon.

Please save the date of 17-19 May 2017 now.

Proceedings of last year’s meeting in Brussels can be found here.

Hope to meet you there!

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Safety & Regulation in Early Clinical Drug Development, 02-Dec-2016

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The BAPU (Belgian Association of Phase I Units) board is pleased to invite you to the BAPU Symposium: “Safety & Regulation in Early Clinical Drug Development”, which will take place on Friday December 2, 2016 at the Marriot Hotel in Gent.

Please find enclosed the programme, registration information and address. Last registration date is Friday, November 11.

Friday, December 2nd, 2016

  • 12:30 Registration and Coffee
  • 13:30 Introduction by the BAPU Chairman Delphine Malisse

Part I: Safety Aspects in Early Clinical Development

Chair: Jan de Hoon, Annick Van Riel

  • 13:40 What makes FAAH so attractive as a CNS target? From bench to clinic. Mark Schmidt, Johnson & Johnson
  • 14:20 The BIAL 10-2474 Accident: Investigator Site Perspective. Alain Patat, Biotrial, France
  • 15:00 Safety Aspects in Phase I Clinical Research: Regulator’s perspective and Recommendations. Walter Janssens, FAHMP
  • 15:30 Panel discussion. Walter Janssens, Mark Schmidt, Alain Patat, Jan De Hoon
  • 16:00 Coffee Break

Part II: EU Regulation – most recent updates

Chair: Sylvie Rottey

  • 16:30 EU Regulation: Considerations on Implementation and effects on Early Clinical Research. Diane Kleinermans, Ministry of Health
  • 17:15 Discussion. Diane Kleinermans, Sylvie Rottey
  • 17:30 Goodbye and Reception

Programme and registration information

See also the BAPU Web site.


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Discount for AHPPI members at ACCP Meeting in Bethesda, MD, Sep-2016

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Registration is open for the 2016 Annual Meeting of the American College of Clinical Pharmacology (ACCP). The meeting runs from 25th – 27th September at the Bethesda N Marriott Hotel & Conference Ctr in Bethesda, MD.

The title of this year’s meeting is Clinical Pharmacology: Discovery & Application in the Era of Precision Medicine.

AHPPI gained ‘Sister Organisation’ status with ACCP when it federated together with AGAH (Germany), BAPU (Belgium) and Club Phase 1 (France) last year to form EUFEMED, the European Federation for Exploratory Medicines Development.

Sister Organisations are entitled to discounts off the registration price for the meeting which brings the Early Bird 3-day pricing down from $1,220 to $960 and the Advance pricing down from $1,515 to $1,275 – well worth the
price of annual AHPPI membership!

A link to the program is included here.ACCP 2016 Theme Final small

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EMA stakeholder activity – User Acceptance Testing of new EU portal

EMA_LogoQ1 2016 saw the User Acceptance Testing of the new EU portal/Clinical Trial Application system begin.

BioKinetic Europe, Niche Science & Technology and Richmond Pharmacology, all of whom have a network of active members in AHPPI are registered testers on behalf of AHPPI and EUFEMED. The new portal is hoped to harmonise the reporting and approval system for the regulatory process for clinical trials across Europe. More information on the Clinical Trial Regulation and EU Portal and Database can be found here.

Release 0.1 covered the functionality to prepare and submit an initial clinical trial application as well as the process of the Member State appointing the reporting Member State. Feedback was consolidated by SGS Belgium.

We look forward to continuing the feedback process and providing input into such an important development for clinical trials as a whole in Europe.


15e87c0Written by Aaron Clements, Associate Project Manager at BioKinetic Europe.

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Evening with the Experts

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This year we shall be offering a new benefit for members.

We are looking to host two hour meetings held in the evening (e.g. 18:00 to 20:00) up to four times a year. The venues would probably be a Phase I unit, Clinical Research Facility, biopharmaceutical company, biotech hub, university etc., or a neighbouring and convenient venue chosen by the host.

The goal is to visit the regions – Cardiff, Manchester, Leeds, Nottingham, Liverpool, Belfast, Edinburgh, Oxford, Cambridge, Guildford and any other notable ‘pharma valleys’ out there.

We’d be looking to arrange for 2 – 3 speakers with at lease one slot offered to the host.

We are expecting the meeting to be free to members. Numbers would be limited by the size of venue and places would be offered on a first come, first served basis.

Some of the topics may shadow elements of the forthcoming EUFEMED human pharmacology diploma curriculum and we will be covering other topical and current issues.

The AHPPI will be coordinating the mailing, marketing etc. and chairing the event in partnership with the host.

Would your company like to host an ‘Evening with the Experts’?

Contact us at info@ahppi.org.uk to express your interest.

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EUFEMED Conference, May 2017, London

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Save the date!

The European Federation for Exploratory Medicines Development (EUFEMED) has scheduled it’s biennial conference for 17-19 May 2017 in London. The AHPPI will be organising the meeting and members will be entitled to a discounted rate. The programme is in development but is expected to include multiple streams:

  • Risk Management in Exploratory Drug Development
  • Regulatory and Operational
  • Scientific Innovations
  • Phase I HV / Patient POC umbrella protocols

‘Day -1’ of the meeting will be pre-conference workshops, and there will also be a call for posters.

Proceedings of last year’s meeting in Brussels can be found here.

AHPPI will keep you updated as the programme develops.

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Club Phase 1 meeting, Paris

Club Phase 1, a group representing early clinical development stakeholders in France, held their 16th Annual Meeting in Paris on 22nd March.

Topics ranged from dealing with immunogenicity to Drug Drug Interactions and a session led by a Biotrial representative on the Bial 10-2474 incident.

You can find the presentations at this link.

Club Phase 1 is a founding member of EUFEMED (the European Federation for Exploratory Medicines Development) that was formally incorporated in May 2015 and also includes AHPPI, BAPUAGAH – the British, Belgian and German professional member associations specialising in human pharmacology.


Nathan McCaveryWritten by Nathan McCavery, Commercial Manager at BioKinetic Europe. Nathan is a member of the AHPPI Organising Committee.

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