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 70 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.
2019 Speakers Include:
Global Operations Lead - Managed Access
Global Medical Lead Orphan Unit
Chief Scientific Officer
Early Access Care LLC
Therapeutic Head Bone Diseases
NYU Working Group on Compassionate Use and Preapproval Access (CUPA)
Chairman, American Living Organ Donor Fund, Ambassador and Rare Disease Patient,
Patient-Center Outcomes Research Institute (PCORI)
Clinical Protocol Manager
Clinical Operations lead for Managed Access
Executive Vice President, Early Access Programs
Early Access Care LLC
Director, Global Medical Affairs, Early Access
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:
- - Clinical/Medical Operations
- - Medical Affairs
- - Regulatory Affairs
- - Market Access
- - Pharmacovigilance
- Contact Research Organisations
- Patient Advocates
- MAP Providers
- Logistics Providers
- Regulatory Consultants
What is the industry saying about Pharma IQ's events?
"Extremely valuable" Policy Director, AstraZeneca
"My knowledge has increased, which I can take back to my organisation"Business Development, MultiPharma, Delegate
"A valuable event providing lots of very useful information and relevant contacts" GMP/GDP Systems Manager, Intercept Pharmaceuticals, Delegate
"Good event, good networking opportunities and relationship building." Regulatory Affairs Manager, Idis, Delegate