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Early Access to Medicines Workshop

EAMS workshop

Date: Friday, 14th September 2018 (Time: 12.00 to 16.45)

Venue: Domenet & Burley Rooms, Faculty of Pharmaceutical Medicine, 19 Angel Gate, 326a City Road, London, EC1V 2PT

Group size: Up to 32 people, theatre-style

Who should attend?: Open to all - members and non-members of the FPM.

Catering: A simple buffet lunch will be served on arrival

Price: £95 (Regular rate - members and non-members) / £65 (in-training (PMST) rate). VAT is not applicable

Bookings will close at 5pm on Thursday 6th September 2018 (subject to places remaining).

See our Terms & Conditions for booking and please note our data protection statement.

Queries: If you are unable to complete your booking online or you would like to be invoiced, please email fpm@fpm.org.uk or call 020 3696 9040.


About the workshop

Early access to medicines programmes are designed to give patients access to medicines before the full process has been completed to grant a marketing authorisation, or licence. This means that patients may gain access to a medicine up to two years earlier than otherwise.

This workshop brings together some of the people at the forefront of the science and regulation of early access schemes to give their insight into what the benefits and risk are, how to submit a good application and how to best work with clinicians and patients. We’ll hear from industry, regulators and patient voices. Essential learning for anyone working in clinical research at any stage and in any therapeutic area.


Time


Topic


Presenter

12.00-13.00 Buffet lunch, coffee and registration
13.00-13.15 Overview and introduction Karen Cheng
13.15-13.50 Early Access to Medicines Scheme
  • Overview of Scheme
  • Application Process
  • Hints and tips for successful applications
  • Dan O'Connor
    Expert Medical Assessor
    MHRA
    13.50-14.25 Industry view on EAMS
  • Benefits
  • Risks
  • Resources
  • Hok Pang
    Medical Lead - Haemato-Oncology, UK & Ireland BMS
    14.25-15.00 Logistics of running an EAMS
  • Planning and operational conduct
  • Submission Package
  • PV Requirements
  • Zahid Bashir
    Independent Pharmaceutical Physician
    Omniac Pharm Consult Ltd
    15.00-15.20 Coffee break
    15.20-15.55 NHS perspective and the views of clinicians
  • Experience from participation in EAMS
  • Robert Fernley
    Programme Manager – Early Access to Medicines Scheme
    NHS England
    15.55-16.30 Patient view on Early Access TBC
    16.30-16.45 Reflections and close Karen Cheng

     

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