The Only Forum to Map the Challenges of Pre-Approved Access Programmes from End-to-End
With ever evolving regulations and the rising number of unsolicited requests from increasingly well informed patients, Pharma must be prepared for any eventuality. However, these obstacles can arise at any time during a Pre-Approved Access Programme, from the point of setting objectives in the early planning stages, to the strategic logistical decisions, or navigating the highly diverse European regulatory landscape through to offering Post-Trial Access Programmes and other operational challenges. The Early and Managed Access Programmes Europe forum brings together over 60 industry leaders to share end-to-end, best practice strategies, to ensure you can fulfil your patients unmet medical needs.
Bringing together over 70 industry professionals, the Early and Managed Access Programmes forum provides a unique platform to enhance the end-to-end process of your Early Access Programme. Through open discussion and high levels of interactivity, this event provides an unrivalled opportunity to solve your challenges across the timeline of your Early Access Programme.
What Will be Covered?
- Navigate the highly diverse European regulatory landscape
- Optimise your pre-approved access programme by streamlining your approach to clinical operations
- Plan for success by setting clear objectives and developing your skills in cross-functional collaboration
- View your pre-approved access programme as part of a continuum of development by effectively and compliantly collecting Real World Data
- Safeguard your patient's access to medicine by hearing best practice case studies in logistical strategy
- Ensure your pre-approved access programme is truly patent- centric by discovering how to engage patients at each stage of the programme, from early planning to close out, and beyond
Who is The Forum For?
- SME and Big Pharma and Biotech, including:
- Contact Research Organisations
- Patient Advocates
- MAP Providers
- Logistics Providers
- Regulatory Consultants
"My knowledge has increased, which I can take back to my organisation"
Business Development, MultiPharma, Delegate
"Good event, good networking opportunities and relationship building."
Regulatory Affairs Manager, Idis, Delegate
"A valuable event providing lots of very useful information and relevant contacts"
GMP/GDP Systems Manager, Intercept Pharmaceuticals, Delegate
2019 Speaker Faculty Includes:
- Gregory Tuyteleers, Global Operations Lead - Managed Access, Janssen
- Peter Rutherford, Global Medical Lead Orphan Unit, Vifor Pharma
- Anne Cropp Pharm.D., Chief Scientific Officer, Early Access Care LLC
- Arun Mistry, Vice President Clinical Development & Medical Affairs Europe, Zogenix
- Dennis Akkaya, Corporate Development, myTomorrows
- Alison Bateman-House, Co-Chair, NYU Working Group on Compassionate Use and Preapproval Access (CUPA)
- Elie Dechesne, Associate Director, R&D Logistics, Bristol-Myers Squibb
- Michael Mittelman, Chairman, American Living Organ Donor Fund, Ambassador and Rare Disease Patient,, Patient-Center Outcomes Research Institute (PCORI)
- Sylwia Stachura, Clinical Protocol Manager, Bristol-Myers Squibb
- Torunn Thingstad, Clinical Operations lead for Managed Access, Janssen
- Alan Thomas, Founder, Ataxia and Me
- Sjaak Vink, CEO, TheSocialMedwork
- Dr. Philipp Schlatter, Community of Practice Leader, Post Trial Access & Drug Supply, Roche
- Tom Watson, Executive Vice President, Early Access Programs, Bionical Emas
- Alita Hassan, Executive Director, Early Access Care LLC
- Karen Frascello, Director, Global Medical Affairs, Early Access, Alnylam Pharmaceuticals
- Dr. Amy Price, Patient Editor Research and Evaluation & CEO, The BMJ & Empower2Go
- Geof Fatzinger, Global Regulatory & Market Access Expert, Caligor Coghlan
- Kevin Myers, (IMP) Distribution Specialist, Clinical Supplies Operations, Bristol-Myers Squibb
- Robert Fernley, Programme Manager - Early Access to Medicines Scheme, NHS England
: 5th-6th November 2019Post-Conference Workshop Day
: 7th November 2019
Please fill in your name and email to receive the Conference Agenda of this event.
VenueHilton London Olympia
380 Kensington High St, Kensington, W14 8NL
Early and Managed Access Programmes - https://www.miceconcierge.com/events/emap
We are delighted to confirm MICE Concierge Ltd are our trusted official accommodation and concierge service for Early and Managed Access Programmes 2019.
MICE Concierge will be providing an enhanced service for all attendees to help ensure you are well looked after whilst you are in London. As our trusted supplier, they have exclusive accommodation rates at the HQ hotel and will ensure you receive the best experience and most importantly the best rates.
We advise you to book through the official channel as the service is supported by the event; you will get the best rates and by staying in one of the accredited hotels you will be with other delegates and will therefore be able to network/socialise more to get the most out of the event.
To view all exclusive rates and to book online, please click here; https://www.miceconcierge.com/events/emapPlease note
: We will never recommend, approve or appoint any third party rooming service to act on our behalf. Please be extremely wary if you are approached by any such companies. We will always endeavour to negotiate the best available rates for you so please use the Hotel's website link provided.