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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10 years after TeGenero – link to the Duff Report

After the TeGenero clinical trial 10 years ago, Professor Gordon Duff led an expert review committee and published a report including 22 recommendations.

The Duff report (published in December 2006), has been removed from the www.dh.gov.uk site, but can be found at http://webarchive.nationalarchives.gov.uk.

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25th AGAH Annual Meeting 2016, Berlin

agah_logoThe Association for Applied Human Pharmacology / Arbeitsgemeinschaft für Angewandte Humanpharmakologie (AGAH) has provided further details of it’s 25th Annual Meeting that will be held this year in Berlin from 20-22 April.


The topic of the meeting will be ‘Exploratory drug development in immunotherapy’.

The immune system is an important target in medicines development. Effective drugs against cancer, viral and bacterial infections or autoimmune diseases have entered the clinic; immunotherapy of cancer was even claimed to be the imminent breakthrough of the year in 2013.

Immunotherapy is the main topic of the upcoming annual meeting of the AGAH. The conference will start with an overview about how to define different approaches and will present an insight into current and future therapeutic opportunities. With respect to early medicines development, the conference will focus on special requirements regarding the development of medicines in this field.

Further details and online registration can be found at http://www.agah.eu/annual-meeting-2016.html.

The Medical Association of Berlin (Ärztekammer Berlin) has accredited the Meeting with 12 CME points.

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

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AHPPI Now Accepting GoCardless Direct Debit payments

GoCardlessAHPPI has launched a new way for you to pay your annual membership subscription, using GoCardless, a simple, secure service to set-up Direct Debit payments on line, authorised by the Financial Conduct Authority. This method will be applicable to holders of GBP bank accounts and should streamline our processes and keep overheads as low as possible.

Visit the Join page of our Web site to start paying your annual membership fee by Direct Debit.

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Institute of Clinical Research partners with Avoca Group for Annual Industry Survey

avocaThe Institute of Clinical Research (ICR) has announced today that it is partnering with the Avoca Group for their Annual Industry Survey. In a mailing sent around to members, the ICR stated:

The focus of this year’s research is on the evaluation of relationships in clinical development and how these have evolved over the past several years. You can access the survey here. As a survey participant, you will receive a complimentary copy of the Executive Summary of the 2016 research results, as well as be entered into a drawing to win one of two $500 (USD) Amazon gift cards. The research results will also be shared throughout industry conferences and publications throughout the year.

If you have something you would like to say about the state of the relationships between stakeholders in clinical development, then please follow the link and complete the survey.

Statement of interests: the author of this item is an AHPPI Managing Committee member and is on the Board of Directors at ICR.

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AHPPI Attending the HRA Phase 1 Advisory Group Meeting, London, 09-Feb-2016

NHS-logoThe National Health Service Health Research Authority (HRA) has a special interest group focusing on Phase 1 clinical trials.

An excerpt from their web site:

The Phase 1 Advisory Group is established by the HRA as a forum to discuss issues relating to the ethical review of Phase 1 trials in the UK. The Phase 1 Advisory Group meets twice a year.

The membership of the Advisory Group comprises representatives of the following:

  • HRA Operations and Approval staff
  • NHS/HSC RECs with Type 1 recognition to review phase 1 trials
  • Phase 1 trials units
  • Association of the British Pharmaceutical Industry (ABPI)
  • Bio-Industry Association (BIA)
  • Contract Clinical Research Association (CCRA)
  • Association of Human Pharmacology in the Pharmaceutical Industry (AHPPI)
  • Medicines and Healthcare Products Regulatory Agency (MHRA)

The Phase 1 Advisory Group (P1AG) meeting minutes can be found on their site (link).

The next meeting will take place in London on 09-Feb-2016.

Representatives from the AHPPI, the UK’s early phase trials membership association, have been attending these meetings since their inception in order to put forward the interests of it’s members.

Further, general information on conducting Phase 1 trials in the UK can be found on the HRA’s site (link).

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