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22 - 24 October, 2018 | Hallam Conference Centre, United Kingdom

Agenda Day 1

8:30 am - 9:00 am Morning Registration and Coffee

9:00 am - 9:05 am PharmaIQ Welcome

9:05 am - 9:15 am Chairman Opening Remarks

9:10 am - 9:50 am Keynote address: The need for collaboration and harmonization across the board

Cristian Brocchieri - Medical Director Alexion Pharmaceuticals
  • Drive regulatory policy harmonization globally by clearly defining Programme terminology
  • Discuss the best practice approach to engage and solicit input from Patients and Caregivers – a manufacturer’s challenge
  • Discover the need for effective communication with the HCPs in order to establish best practice for data capture 
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Cristian Brocchieri

Medical Director
Alexion Pharmaceuticals

9:50 am - 10:30 am Creating a Strategy for a Successful Early and Managed Access Launch

Samantha Nunes Radimerski - PhD, Medical Governance Lead, Managed Access Programs, Chief Medical Office Novartis Pharma AG
  • Define programme implementation criteria and drive engagement across different functions
  • Discuss case studies of successful programme launch and understand difference in approaches
  • Understand the key challenges in internal communication and best practice in company-wide roll-out
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Samantha Nunes Radimerski

PhD, Medical Governance Lead, Managed Access Programs, Chief Medical Office
Novartis Pharma AG

10:30 am - 11:00 am Morning coffee break

11:00 am - 11:40 am Case Study: An Inside Look at Managing an Early Access Programme

Venkata Sravan Jaggumantri - Clinical Scientist, Rare Diseases & Scientific Affairs PRA Health Sciences
  • Define best approach for cross-functional collaboration pre-launch from a rare disease perspective
  • Explore patient inclusion and HCPs engagement and managing expectations
  • Examine criteria for a successful launch and followed programme operational management CROs perspective
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Venkata Sravan Jaggumantri

Clinical Scientist, Rare Diseases & Scientific Affairs
PRA Health Sciences

  • Strategies for a successful programme launch
  • Regulatory differences between the US & EU
  • Approaches to reimbursement 
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Hartwig Gajek

Managing Director
Hesyra-Medical GmbH

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Allison Morgan

Managing Director
Metis Clinical

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Dimitri F. Dimitriou

Chief Executive Officer
ImmuPharma plc

12:40 pm - 1:40 pm Networking Lunch Break

1:40 pm - 2:20 pm Case Study: Outlining a Successful Reimbursement Strategy

Pedro Franco - Director Europe, Global Regulatory & Scientific Policy (GRASP) Merck Serono
  • Analyse the reimbursement controls in different European countries
  • Discuss issues around pricing criteria including pricing increases and reductions
  • Understand the administrative arrangements around reimbursement
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Pedro Franco

Director Europe, Global Regulatory & Scientific Policy (GRASP)
Merck Serono

2:20 pm - 3:00 pm Interactive Session: Best Strategies for Funding

Dimitri F. Dimitriou - Chief Executive Officer ImmuPharma plc
  • Debate the challenges of small vs big pharmaceutical companies in developing a successful EMAPs strategy
  • Define criteria and mitigate risks for small and specialty pharma manufacturers
  • Discuss the possibility of non-competitive collaboration in best practice and terminology harmonisation
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Dimitri F. Dimitriou

Chief Executive Officer
ImmuPharma plc

3:00 pm - 3:40 pm Afternoon Coffee Break

3:40 pm - 4:20 pm Early Regulatory Strategic Insights

Hartwig Gajek - Managing Director Hesyra-Medical GmbH
  • Create successful global regulatory strategies for early access programmes
  • Analyse the differences in national requirements
  • Discover how your peers are complying on a global scale
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Hartwig Gajek

Managing Director
Hesyra-Medical GmbH

4:20 pm - 5:00 pm Panel Discussion: Regulatory Landscape and Government Understanding of Terminology within Programmes

Cristian Brocchieri - Medical Director Alexion Pharmaceuticals
Pedro Franco - Director Europe, Global Regulatory & Scientific Policy (GRASP) Merck Serono
  • Define country understanding on terminology and influence on policy roll-out
  • Discuss country intelligence outside of USA and EMEA
  • Analyse strategies for policy harmonisation
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Cristian Brocchieri

Medical Director
Alexion Pharmaceuticals

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Pedro Franco

Director Europe, Global Regulatory & Scientific Policy (GRASP)
Merck Serono

5:00 pm - 5:30 pm Chairman’s Closing Summary of Day One


5:15 pm - 6:15 pm Networking Drinks Reception