Well over a decade at the heart of medicines regulation in the EU, a strong technical background in clinical trial methodology and quantitative sciences and unparalleled experience in reviewing and improving clinical development programmes and developing successful regulatory strategies.Expert in: - standards for regulatory decision making- regulatory pathways and procedures to support authorisation - use of innovative clinical trial designs to support development and authorisation- the role of real world data in drug development and for post-authorisation evidence generation- applying Quantitative Sciences to support drug development and licensing- facilitating complex multi-disciplinary discussions
Consilium, Salmonson And Hemmings
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PartnerConsilium, Salmonson And Hemmings 2019 - PresentLondon, United KingdomConsultancy to the pharmaceutical industry, governmental and non-governmental organisations on medicines research and development and regulatory strategy, policy and procedures.
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Committee For Medicinal Products For Human Use (Chmp) MemberEuropean Medicines Agency 2008 - 2019Highly influential committee member with a broad portfolio of Rapporteurships.Co-opted to the committee for expertise in clinical trial methodology and epidemiologyKey to the development and implementation of PRIMEContributions to multiple therapy-area, technical and regulatory guidance documents, including Conditional Marketing Authorisation and Post-Authorisation Efficacy Studies.An EU representative to ICH. -
Prime (Priority Medicines) Oversight CommitteEuropean Medicines Agency 2016 - 2018London, United Kingdom
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Chair Of Scientific Advice Working PartyEuropean Medicines Agency 2010 - 2018Facilitating complex multi-disciplinary discussions, finding solutions to difficult issues, and developing regulatory policy and standards across the breadth of drug development.
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Chair Of Biostatistics, Modelling & Simulation And Extrapolation Working PartiesEuropean Medicines Agency 2009 - 2018Key to the development of these disciplines in the EU regulatory network and to the integration of these disciplines into regulatory decision making.Co-author of guidelines on Extrapolation, Subgroups, Adaptive Designs, Missing Data, and the draft ICH E9(R1) on Estimands and Sensitivity Analysis.
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Head Of Statistics And Pharmacokinetics, Licensing DivisionMedicines And Healthcare Products Regulatory Agency 2000 - 2019 -
Scientific Advice Working Party MemberEuropean Medicines Agency 2006 - 2008
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StatisticianAstrazeneca 1996 - 2000
Frequently Asked Questions about Robert Hemmings
What company does Robert Hemmings work for?
Robert Hemmings works for Consilium, Salmonson And Hemmings
What is Robert Hemmings's role at the current company?
Robert Hemmings's current role is Partner at Consilium, Salmonson and Hemmings.
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