9th November 2021
Digital Conference - All TIMINGS IN GMT
Webinar Day One
12:25 pm - 12:30 pm
PharmaIQ Welcome
12:30 pm - 1:10 pm
Managing Your Country Selection and Product Allocation for Effective and Equitable Market Management
- Factors to consider when designing an effective strategy for your programme country selection
- Discuss the ongoing challenges of product allocation and supply management across global markets
- Identify – in so far as it is possible – the critical success factors in proactively managing your product and programme portfolio across global markets
1:10 pm - 1:50 pm
Collection and Application of Real World Data (RWD) through Early Access Programs in Europe
- Outline key regulatory considerations in the EU5
- Discuss practical examples of application and utilisation of RWD
1:50 pm - 2:30 pm
Covid-19 as a catalyst for innovation and development within J&J’s Managed Access Programmes
· Direct to patient models
· Putting the patient at the center of your trial – ways of incorporating different product formats etc
· Global distribution management and lessons learned
2:30 pm - 3:00 pm
Coffee Break
3:00 pm - 3:40 pm
Expanded Access, a strategic imperative for Pharmaceutical companies
· Analyse the continued evolution of Expanded Access
· Assess opportunities of Real-World Data: a viable option to create value for all stakeholders
· Case Study: Expanded Access & RWD Collection
· Discuss what to expect going forward?
Dennis Akkaya, Corporate Development, myTomorrows
3:40 pm - 4:20 pm
Designing Strategic Early Access Solutions for Rare Disease Drugs
4:20 pm - 6:00 pm
Co-Creating Expanded Access Resources: Transforming information for transparency
In this session, you will have the opportunity to:
- Discuss experiences in identifying potential treatment options
- Review and provide input into new EA patient resource
- Join a global dialogue about EA
5:00 pm - 5:40 pm
Considerations When Collecting RWD and Extracting RWE: A Statistician's Perspective
· Establishing a Delineation between RWD and RWE
· Decisions on collecting data - what is meaningful and what you can draw evidence from
· Analysing why the data was collected, how much data is or needs to be collected and what is the quality of the data
