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    • Beneficiaries
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    • People >
      • Supervisors >
        • Prof. B. Griffin
        • Prof. M. Kuentz
        • Dr. C. Saal
        • Dr. L. Kalantzi
        • Dr. E. Kostewicz
        • Prof. C. Reppas
        • Prof. J. Dressman
        • Dr. N. Fotaki
        • Dr. R. Holm
        • Dr. M. Vertzoni
        • Dr. K. Box
        • Prof. C. O'Driscoll
      • Researchers >
        • Niklas Köhl (ESR1)
        • Felix Ditzinger (ESR 2)
        • Daniel Price (ESR 3)
        • Georgia Tsakiridou (ESR 4)
        • Sandra Jankovic (ESR 5)
        • Chara Litou (ESR 6)
        • Christina Pentafragka (ESR 7)
        • Rafael Leal Monteiro Paraiso (ESR 8)
        • Laura Henze (ESR 9)
        • Patrick O'Dwyer (ESR 10)
        • Marina Statelova (ESR 11)
        • Mariana Guimarães (ESR 12)
        • Ioannis Loisios-Konstantinidis (ESR 13)
        • Alexandra-Roxana Ilie (ESR 14)
        • Angela Effinger (ESR 15)
      • Scientific Advisory Board >
        • Prof. Carla Caramella
        • Dr. Paul Dickinson
        • Dr. Andrea Edginton
        • Dr. Susanne Keitel
        • Dr. Mehul Mehta
    • PEARRL Wiki >
      • FAQ
      • Glossary
  • Research
    • Workplan
    • WP1: Bio-enabling formulations
    • WP2: Biopharmaceutical tools
    • WP3: In silico methods
    • Results >
      • Scientific Publications
      • Conference Contributions
      • InfoPEARRLs
      • Media
  • Training
    • Local
    • Network-wide
    • PEARRL Online Learning Portal
    • Member Area
  • News
  • Events & Meetings
    • Webinar: Regulatory Science Apprentice
    • Annual Meeting 2019
    • Model Informed Drug Development Symposium 2019
    • Annual Meeting 2018
    • Regulatory Science Symposium 2018
    • Annual Meeting 2017
    • Regulatory Science Symposium 2017
    • PEARRL Calendar
    • International Conferences
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Pharmaceutical Education And Research with Regulatory Links.

Regulatory Science Symposium
18 & 19th June 2018, Johann Wolfgang Goethe University, Germany

PEARRL is an EU research and training network focused on exploring new ways to streamline drug product development to facilitate earlier access to innovative new medicines.  Regulatory initiatives such as “Earlier Access to Medicines” (MHRA, 2014) and “Adaptive Licensing”(EMA, 2014) highlight the recent  increasing role regulatory agencies are playing in supporting this area[1].   A key objective of PEARRL is to increase awareness of advances in Regulatory Science (i.e. the science of “developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of regulated products”). 

Building on the success of the 2017 symposium, PEARRL will host a second Regulatory Science Symposium at the Johann Wolfgang Goethe University in Frankfurt, on 18th & 19th 2018.

​The theme for Day 1 of the 
Open Symposium is an 'Overview of in silico tools to support Regulatory applications' .
 
Day 2 of the symposium will be focused on providing an 'Overview of Tools for investigating dosage form behaviour in vitro that can be used in regulatory applications'

An outline agenda for both days is provided below.

If you are interested in attending one or both days of the Regulatory Symposia, you  should register your interest in attending on the field below.  There is no charge for registration but places are limited, so you must register by the 1st June if you wish to attend. 
​

Day 1 - Agenda (provisional)

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Day 2 - Agenda (provisional)

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Invited Speakers (Provisional list)

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Dr. Mehul Mehta
Director, DCP I (Division of Clinical Pharmacology I), OCP (Office of Clinical Pharmacology), in CDER (Center for Drug Evaluation and Research), FDA; USA
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Dr. Andrea Edginton
Associate Professor, Programmatic Assessment Officer, School of Pharmacy, University of Waterloo, Canada
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Prof. Werner Weitschies
Department of Biopharmaceutics and Pharmaceutical Technology, University of Greifswald, Germany
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Dr. Richard Barker
Pharmaceutical Development Biopharmaceutics, AstraZeneca, United Kingdom
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Dr. Rodrigo Cristofoletti
National Health Surveillance Agency (ANVISA), Brazil
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Prof. Anette Müllertz
Pharmaceutical Design and Drug Delivery, University of Copenhagen, Denmark
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Dr David Turner
Simcyp Limited (A Certara Company)
Sheffield, United Kingdom

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Dr Oliver Hatley
Simcyp Limited (A Certara Company)
Sheffield, United Kingdom


About PEARRL
PEARRL is a European Training Network (ETN) funded under the Horizon 2020 Marie Sklodowska-Curie actions. It brings together European Pharma industry, academia and regulatory agency partners in a multisectorial team to deliver a unique research and training programme for 15 Early Stage Researchers (ESR).

The main research objectives of the PEARRL research programme are to deliver novel bio-enabling formulations and new biopharmaceutics tools to predict their in vivo performance as a means to improve efficiency and cost-competitiveness in drug development, thus facilitating earlier access of patients to “breakthrough therapies”.

PEARRL will train 15 Early Stage Researchers (ESR) who can develop such new bio-enabling formulations (“better drugs”), biorelevant and in silico methods to predict formulation performance in vivo (“streamlined development”) and serve as communication bridgers between research and regulatory science (“accelerated approval”), thus bringing Pharma and regulatory objectives to fruition.

Registration for the PEARRL Regulatory Science Symposium is now closed

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This project has received funding from the European Union’s Horizon 2020 Research and Innovation Programme under grant agreement No 674909.
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