Meet NDA at DIA USA and BIO conventions



Already Europe’s leading drug development consultancy, NDA Group, has been broadening its reach into the USA over the last two years, with offices established in Boston and Princeton. Through our expanding activities in the US we supported over 20% of new drugs that achieved approval by the FDA during 2016.

This June, NDA will be attending the DIA USA and BIO convention with a strong line-up of world-leading speakers and experts.

The 53rd DIA Annual Meeting 2017 is being held on June 18-22, at McCormick Place, Chicago. Whilst, the BIO International Convention is on June 19-22, at San Diego Convention Center, San Diego.

If you are planning to attend this year’s DIA or BIO, we would really like to meet up with you. If you’d like to arrange a meeting with us, please email

Hear the experts

NDA’s experts will present on a number of critical drug development related topics at both the DIA and the BIO meeting.




Neelu AgarwalPete_TaftNeelu Agrawal, Principal, PharmApprove

Pete Taft, Founder and Chief Executive Officer, Taft and Partners/PharmApprove


Tutorial:  Preparing for a US FDA Advisory Committee Meeting
Track: 5 Regulatory Affairs #30
Day: Sunday June 18
Time: 13:00 – 16:30


Shelley_GandhiShelley Gandhi, Pharmacovigilance and Drug safety Expert expert, NDA Group
Title: The Good Pharmacovigilance Practices in the EU: Global Applications
Track: 6 Safety & PV #43
Day: Sunday June 18
Time: 09:00 – 17:00

Title:  Future Regulatory Goals of the Periodic Benefit-Risk Evaluation Reports (PBRER ): Are They Being Achieved?
Track: 6 Safety & PV #280 Developing Pharmacovigilance Policy based on Impact
Day: Tuesday June 20
Time: 16:00 – 17:15


Lesley_WiseLesley Wise, Principal Consultant, Pharmacoepidemiology, NDA Group
Title: Incorporating Patient Preferences in Benefit-Risk Assessments: Interpreting ICH M4E (R2)
Track: 4 Patient Engagement, Forum #251 Defining the Science of Patient Input to Enhance Drug Development & Approval: Regulatory
Day: Tuesday June 20
Time: 14:00 – 15:15




Lisa-PelusoMarkku ToivonenLisa Peluso, Director Coaching and Client Engagement, PharmApprove

Markku Toivonen, Scientific Director, NDA Group


Title: Bridging the Atlantic: How to Involve Patients in Orphan Drug Development and Approval Processes Given Differences between FDA and EMA
Day: Wednesday June 21
Time: 15:00 – 16:00 Room 3


NDA has been at the forefront of developing services for the life science industry that take advantage of addressing evidence generation requirements of regulatory as well as HTA bodies. Since its inception in 1997, NDA has been guiding over 1 000 different life science companies of all sizes on the direction and actions needed to meet regulatory and payer needs in major markets.


NDA in the USA

At the beginning of 2015, NDA opened up an office in Boston to cater for growing client demand for its services in the USA. Already working with many US based global and local pharmaceutical and biotech companies, NDA established a dedicated office in the USA to better support and service the needs of clients in the region.

NDA supported over 40% of the new medicinal products that were approved in the EU during the past four years. In 2016 NDA merged with PharmApprove, the market leader in managing critical FDA interactions to help us achieve the same results in the US. Through our expanding activities in the US we supported over 20% of new drugs that achieved approval by the FDA during 2016.

To find out more or schedule an appointment with members of the NDA team, please email

We look forward to hearing back from you about a meeting and to seeing you at the events!