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WODC Barcelona 2017

November 13 @ 08:00 - November 15 @ 17:00 UTC+0

Event Dates/Times:

Pre-Congress Workshops - 13 November 2017

  • Afternoon Workshop Hosted by Mapi Group: 13 November 2017 @ 13:00 - 17:30

Main Event -  November 14 - 15, 2017

  • Conference Day 1:  14 November 2017 @ 09:00 - 18:00
  • Conference Day 2:  15 November 2017 @ 09:00 - 18:00

Event Venue:

Avenida Diagonal 661 671, Barcelona, Spain, 08028

Event Description:

Join Mapi's experts @ WODC Barcelona 2017! Visit us at Booth #5

The 8th annual World Orphan Drug Congress is the marketplace for orphan drug professionals looking at the complete value chain of orphan drug development, from clinical development and R&D to corporate development and market access. Being Europe’s largest Orphan Drug Congress, this event will provide a platform for you to showcase your thought leadership and expertise pharma, biotechs, payers, regulators and patient advocates.

Join us in November and make sure you are at the forefront of the orphan drug industry. Regardless of whether your interest lies in research, clinical development, patient access, global pricing and reimbursement or just to engage with patient advocacy groups more intimately, we have content, networking and potential partners for you. Take just three days out of the office to meet with 400 potential customers who need to find solutions to challenges around the commercial, regulatory and scientific issues in orphan drugs.

Through strategic keynote plenaries, themed tracks, and dedicated networking sessions, you have the chance to really tailor the event to the needs of your day-to-day role. Book your place today via the show website at www.terrapinn.com/orphandrugeu.

Mapi's Pre-congress Workshop Agenda:

Assuring success from Regulatory to Global Market Access of Rare Disease Treatments

Presentation #1: "Partnering with Patients for Clinical Success"

Kelly Franchetti, RN, CCRN, CEN - Vice President, Global Patient Insights and Engagement (PI&E), Patient-Centered Sciences (PCS), Mapi Group

This interactive workshop will introduce participants to a 360° approach to obtaining patient insights and applying them to the successful design and execution of clinical studies. Through engaging activities, we will address how to get to the heart of the patient’s decision-making process, assess their physical/emotional/social needs, and identify their motivators, barriers, and influencers as they relate to clinical study participation.

Participants will then learn how insights are analyzed and applied in order to:

  • Design studies that appeal to the targeted patients
  • Determine effective and motivating recruitment methods
  • Engage and communicate with patients and caregivers
  • Identify retention methods that meet the needs of a specific patient population
  • Develop materials that resonate with patients and caregivers

Presentation #2: "An Introduction to the Science of Endpoint Design in the Current Regulatory & HTA Environment in the US & Europe"

Rory Graham - Senior Director, EU Regulatory Services, Mapi Group

Martine Zimmermann - Global Head of Regulatory Affairs, Alexion Pharma GmbH

 

  • Regulatory strategies for early scientific advice: FDA & EMA scientific advice, PRIME & adaptive pathways link to scientific advice
  • The creation, categorization, and hierarchy of endpoints and requirements of different stakeholder groups, including regulatory agencies, clinicians, HTA bodies, payers, increasingly active patient groups
  • Real-life examples of endpoints used in selected therapeutic area & techniques for the development and validation of new endpoints
  • Highlighting guidance and publications that will be of use to newcomers to the area
  • Solving the non-alignment between different agencies and geographical  differences in approach

Methodologies in developing Real World Data: Engaging stakeholders in developing evidence strategies

How is expanded access used to provide treatment for patients with rare diseases?

Compassionate Use Programs in the window between submission and commercialization

What are the benefits of conducting clinical studies and registries for rare diseases?

What are the types of studies conducted during different phases of orphan drug development?

How are patient registries used to generate real-world data for rare diseases and orphan drugs?

Ethical Patient Warehousing – working with Advocacy to identify populations in advance of research

What are the unique challenges of conducting rare disease/orphan drug registries?

How can proactive study management strategies successfully address these challenges?

Potential risk mitigation strategies, and alternative registration strategies will be discussed.

Dr Will Maier, Chief Scientific Officer and Head of Patient-Centered Sciences, Mapi Group

17.00 End of Workshop Followed by Networking Drinks Hosted by Mapi Group


Featured Mapi Presentations/Speakers @ #WODCEurope's Main Event (2-Day Congress):

14th November 2017 @

Catherine Acquadro, MD - Global Lead Scientific Presentation and Publications, Mapi Group


Register to attend:

http://www.terrapinn.com/conference/world-orphan-drug-congress/index.stm

Details

Start:
November 13 @ 08:00
End:
November 15 @ 17:00
Event Category:
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