The market access environment is getting increasingly challenging. The ability to develop plans and strategies for access, for today as well as tomorrow, is critical to bring new medicines to patients.
In this seminar our presenters will share their experiences and provide their insights and considerations to optimize the value of your development program.
- How to secure value in your development program considering both regulatory and market access requirements
- Learn about how, when and why it is critical to consider HTA and market access requirements in your development program
- Understand how to mitigate differences in demands/requirements between regulatory and HTA bodies
Claes Buxfeldt, HTA Director at NDA Group. with over 20 years’ experience in the market access and health economic areas. Claes has extensive experience in developing the market access strategy/payer evidence generation for drug development programs from pre-clinical to launch phase.
Stephanie Krumholz, Former General Manager of the Swiss NDA Affiliate with a demonstrated history of working in the pharmaceuticals and biotech industry across multiple therapeutic areas in all phases of drug development. Expertise in EU, US and Swissmedic Marketing Authorisation Filings and conducting Due Diligence for clients.
Professor Steffen Thirstrup, Former Director NDA Advisory Board, Former Head of Division, Medicines Assessment and Clinical Trials, Danish Health and Medicines Authority, and CHMP member. Steffen is an expert in clinical development and regulatory strategies.
Professor Mira Pavlovich-Ganascia, NDA HTA Advisory Board member, practicing physician and former Deputy Director for HTA at the Hauté Autorité de Santé (HAS), France. Mira is an expert in HTA activities related to early dialogues with developers, disease-specific guidelines and methodology of assessment for reimbursement purposes.
09:00 am – Welcome – Claes Buxfeldt, Director NDA HTA Advisory Board and Stephanie Krumholz, General Manager NDA Switzerland
09:15 am – Session 1: Challenges in drug development – Professor Steffen Thirstrup
10:15 am – Coffee break
10:35 am – Session 2: HTA and Europe – where are we heading? – Professor Mira Pavlovich – Ganascia
12:05 am – Concluding remarks and take home messages
13:15 – 15:30 pm – Ask the Experts – To book a 20 min slot to speak directly with our experts send an email to firstname.lastname@example.org
Date: Tuesday 3rd of December 2019
Time: 09:00 am – 12:15 pm (with the opportunity to book 1-1 meetings from 13:15)
Venue: Bio-Technopark, Auditorium, Wagistrasse 25, 8952 Schlieren
The seminar will be an open and interactive workshop with the opportunity to ask our presenters questions. Specific questions can also be sent in advance to email@example.com Indicate if you would like to discuss them openly during the meeting, otherwise we can book separate meetings to discuss them after the seminar.
Registration: RSVP by Friday 29th November 2019 to firstname.lastname@example.org
Contact: Stephanie Krumholz, General Manager Switzerland, +41 78 951 9929, or email email@example.com
If you are unable to attend, please advise us no later than two days before the seminar.
We look forward to seeing you there!