Already a DIA Member? Sign in. Not a member? Join.

Sign in

Forgot User ID? or Forgot Password?

Not a Member?

Create Account and Join

Hotel Grand Majestic Plaza

Jun 15, 2017 8:15 AM - Jun 16, 2017 5:00 PM

Truhlarska 16, 110 00 Prague 1, Czech Republic

DIA Workshop on Benefit-Risk Strategy

Session 6: PRAC Referrals – Lessons Learned

Session Chair(s)

Martin  Huber, MPH, MPharm

Martin Huber, MPH, MPharm

Pharmacovigilance Risk Assessment Committee (PRAC) Vice Chair

Federal Institute for Drugs and Medical Devices (BfArM), Germany

Martin  Votava, MD, PhD

Martin Votava, MD, PhD

Chief Medical Officer

PrimeVigilance, Czech Republic

Pharmacovigilance referrals are important tools to address concerns over the safety profile or the benefit-risk balance of a medicine or a class of medicines. This session will look into finished referrals but will also reflect on future challenges both from a regulator’s and industry perspective. The following aspects will be discussed: - Describing the evolution of referrals including recent trends - Reflecting on what can be learnt from experience gathered so far - Looking into future challenges – what can be improved?


Álmath  Spooner, PhD

Referrals at PRAC – Recent Trends and Future Challenges

Álmath Spooner, PhD

AbbVie, Ireland

Head of Europe Regulatory Policy & Intelligence (RPI)

Vera  Tóth, MD

Implementing CHMP/PRAC Conditions: Pitfalls and Challenges

Vera Tóth, MD

Gedeon Richter Plc., Hungary

Medical Expert

Have an account?

Be informed and stay engaged.

Don't miss an opportunity - join our mailing list to stay up to date on DIA insights and events.