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Global Regulatory and Submissions Management in the Pharmaceutical Industry
09. February - 10. February 2017, Vienna

Harmonization: Towards a uniform architecture

by Dr. Klaus Menges (BfarM)

Data sharing and transparency

Global Life Cycle Management strategy

KEY TOPICS

Regulatory intelligence and its practical impact

eCTD and MAA special cases

EU Telematic strategy towards 2020

CESP, communication and expectations of different stakeholders

TAKEAWAYS AND SPECIAL FEATURES

  • Merck’s strategy for integrating regulatory intelligence in development teams and regional submission strategies

  • Sanofi's strategy for the worldwide registration of the Dengue vaccine

  • IDMP readiness – a case study of a long-established medium-sized company

  • First-hand approaches to how to plan the regulatory strategy that best suits your company

  • A basis for improving communication leading to time-efficient submissions and approvals

  • “Set your personal takeaways” sessions

  • Meet the authorities

  • People Bingo: Ice breaker and networking activity

  • Brexit - Panel discussion

  • 10+ interactive sessions

Get the complete program line-up, speaker details. Download agenda by clicking on the link below.

Speakers

Klaus Menges photo
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Klaus Menges

PharmNet.Bund Authorised Representative at BfArM

Considering the broad regulatory experience as well as the experience on IT solutions in the drug regulatory affairs area, the BfArM assigned contribution to the PharmNet.Bund project, which became th

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Richard Pilsudski

Vice President Global Regulatory Affairs at SANOFI PASTEUR

Richard Pilsudski received his Ph.D in Cardiac Electrophysiology in 1989 from the Claude Bernard University in Lyon, France. He started his career in Pharma at Wyeth as a Clinical Scientist in 1990.

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Dr Susan Bhatti photo
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Dr Susan Bhatti

Director EU Global Regulatory & Scientific Policy at Merck KGaA

Having has worked in Regulatory Affairs for more than 20 years, Dr Bhatti has an in-depth understanding of the value of pertinent regulatory intelligence when planning and executing regulatory submiss

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Keith McDonald

Deputy Director of Licensing Division at Medicines & Healthcare Products Regulatory Agency

Keith McDonald joined the UK Medicines Control Agency in 1997 and has held positions as pharmaceutical assessor, Unit and Group Manager and was appointed to the position of Deputy Director in 2015. He

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Want to attend Global Regulatory and Submissions Management in the Pharmaceutical Industry? Register now!

Venue

Vienna, Austria