Live Chat Software
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 - 9:10 am Chairman Opening Remarks

9:10 am - 9:45 am Keynote address: The need for collaboration and harmonization across the board

David Farber - FDA Life Sciences Partner, King & Spalding
  • 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 
img

David Farber

FDA Life Sciences Partner
King & Spalding

9:45 am - 10:20 am Creating a Company Strategy and Procedure for Successful Handling of Managed Access Requests

Ramona Reichenbach - Global Medical Governance Lead – Global Governance Office, Novartis Pharma AG
  • Define programme implementation criteria and so that you can map your implementation journey
  • Understand the key challenges and questions to be considered when mapping your implementation strategy
  • Analyse best practice in company-wide roll-out for successful project management
img

Ramona Reichenbach

Global Medical Governance Lead – Global Governance Office
Novartis Pharma AG

10:20 am - 10:55 am How to serve more patients and learn from trial-adjacent populations

Dennis Akkaya - Corporate Development, myTomorrows
- Identify key challenges of recruiting patients for drug development trials
- Overcome failure to treat and the failure to learn to minimise re-occurance in future programmes
- Combine expanded access with real-world data to generate the most holistic program insight
img

Dennis Akkaya

Corporate Development
myTomorrows

10:55 am - 11:30 am Morning coffee break

11:30 am - 12:10 pm 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
img

Venkata Sravan Jaggumantri

Clinical Scientist, Rare Diseases & Scientific Affairs
PRA Health Sciences

  • Define country understanding on terminology and influence on policy roll-out
  • Discuss country intelligence outside of USA and EMEA
  • Analyse strategies for policy harmonisation
img

Pedro Franco

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

img

Karen Frascello

Vice President of Marketing and Business Development
Caligor Coghlan

Nisha Shaunak

Lead Pharmacist for Oncology, Guy’s and St Thomas’ & Specialised Cancer Commissioning Pharmacist
NHS

img

Ramona Reichenbach

Global Medical Governance Lead – Global Governance Office
Novartis Pharma AG

1:00 pm - 2:00 pm Networking Lunch Break

Nisha Shaunak

Lead Pharmacist for Oncology, Guy’s and St Thomas’ & Specialised Cancer Commissioning Pharmacist
NHS

2:50 pm - 3:30 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
img

Pedro Franco

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

3:30 pm - 4:00 pm Afternoon Coffee Break

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

Hartwig Gajek

Managing Director
Hesyra-Medical GmbH

img

Allison Morgan

Managing Director
Metis Clinical

img

Dimitri F. Dimitriou

Chief Executive Officer
ImmuPharma plc

4:50 pm - 5:30 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
img

Dimitri F. Dimitriou

Chief Executive Officer
ImmuPharma plc

5:30 pm - 5:40 pm Chairman’s Closing Summary of Day One


5:20 pm - 6:20 pm Networking Drinks Reception