Conference Agenda

Pre-Conference Workshop

Monday 19th October 2020

Workshop A:
Opportunity for Real-World Evidence in Improving Patient Outcomes

 

AGENDA

9:00 – 10.30am - Interactive presentation
10:30 – 11:00am - Networking break
11:00 – 12:30pm - Interactive presentation and Discussion

 

ABOUT

Observational studies using real-world evidence (RWE) provide significant opportunities to gain insight into treatment patterns and outcomes in clinical practice outside randomized controlled trials. RWE is being widely used to gain an understanding of disease epidemiology, patient journey, real-world use and effectiveness of treatment options, unmet patient needs and the value that products offer in sub-populations. In this workshop, you will learn the opportunities and benefits of RWE.

 

WHO IS IT FOR?

This workshop is ideal for anyone who wishes to become familiar with key issues in the areas of real-world evidence. It is particularly relevant to individuals working for Pharma/Biotech companies, regulatory authorities, HTA bodies, patient organizations, consultancy and academic institutions.

 

Workshop B:

Successful application to global market access for orphan drug therapies

 

AGENDA

9:00 – 10.30am - Interactive presentation
10:30 – 11:00am - Networking break
11:00 – 12:30pm - Interactive presentation and Discussion

 

ABOUT

Learn more about how can manufacturer meet global patient demand for access to medicines prior to approval. This will also discuss some of the methods that orphan drug manufacturers can do to partner with governments to bring orphan drugs to the market. R&D strategies to be implemented to accelerate market access for orphan drugs will also be explore. And how can patient, governments and orphan drug companies help support each other’s initiative to provide market access to patients?

 

WHO IS IT FOR?

This workshop will be extremely beneficial to those individuals involve in development, commercialization and market access of orphan drugs. Project Managers and Executives in Pharma/Biotech companies, consultancy, Patient Advocacy, interested in knowing how to successfully launch an orphan drug.

Workshop C

Managed Access/Early Access Programme

ABOUT

This interactive presentation will provide you with an opportunity to learn more about how EAP’s provide pre -launch access for drugs in advance of their Marketing Authorization (MA) for patients with life-threatening conditions and no approved treatment options. Best practices in EAP planning, Set-Up and management, and provide information on current regulatory changes

WHO IS IT FOR?

This workshop will be extremely beneficial to those individuals considering an EAP as part of their drug development strategy. Project Managers and Executives in Pharma/Biotech/Advocacy interested in knowing how to set-up an Early Access Program.

AGENDA

13.30 - EAP Perceptions, fears, hopes & knowledge

14.00 - Case- study – GENE THERAPY MAP

14.15 - Introduction to MAP – regulatory overview and patient and HCP perspective

15.00 - Break

15.30 - Case – study – GLOBAL CNS MAP

15.45 - Implementing a MAP

- Functions - Considerations

- Timings - Charging

- Costs

16.30 - Case – study – GLOBAL Oncology MAP

16.45 - How we go forward

Presenter:

Robert Donnell, Head of Business Development

Supported by: Dan Piggott / Todd Galles

 

Workshop D

Conquering logistical challenges: Developing a patient-centric approach to improve clinical trial retention

AGENDA

13:30 – 15:00pm - Interactive presentation

15:00 – 15:30pm - Networking break

15:30 – 17:00pm - Interactive presentation and Discussion

ABOUT

This workshop will tackle issues and potential solutions on how to conquer logistical challenges of small or geographically dispersed patient population and also limited number of investigator sites. As patient recruitment and retention is a challenge most of the sponsor are facing, there is a need for a patient-centric focus to enable patients to participate in clinical trials with less disruption to their daily routine.

WHO IS IT FOR ?

This workshop is ideal for anyone who wishes to become familiar with key issues in the areas of rare diseases and orphan drugs clinical trials. It is particularly relevant to individuals working for Pharma/Biotech companies, regulatory authorities, Research and Development, patient organizations, consultancy and academic institutions.

Interested in leading a workshop or master class?

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