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

Harmonization: Towards a uniform architecture

by Dr. Klaus Menges (BfarM)

Data sharing and transparency

Global Life Cycle Management strategy


Regulatory intelligence and its practical impact

eCTD and MAA special cases

EU Telematic strategy towards 2020

CESP, communication and expectations of different stakeholders


  • 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.


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

Learn more about Klaus >

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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

Learn more about Dr Susan >

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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

Learn more about Keith >

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François Verdier

Associate VP, Regulatory Affairs at Sanofi Pasteur

François Verdier received his Pharm.D in Lyon in 1986 and his Ph.D in Immunotoxicology in Paris in 1993. He started his career in Toxicology with a Contract Research Organization (MDS) from 1988

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Renaissance Wien Hotel, Vienna, Austria
Besides being the capital and largest city in Austria, Vienna is also the cultural, political and economic center of the country. Located at the crossroads between Eastern and Western Europe, the city unsurprisingly ranked six times in a row as the number one destination for international congresses and conventions. Vienna host many international organizations and is considered to be one of the best places for innovation.