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Regulatory Science (RS) Community

The Regulatory Science Community represents a diverse community of scientists from biopharmaceutical industry, government, and academia who are interested in the science of clinical pharmacology and translational medicine and the application to the drug development process, with an ultimate aim to enhance patient care.

Community Goals

The goal of the Regulatory Science Community is to promote interaction between drug development scientists, clinicians, and regulators to facilitate integration of a broad expanse of skill sets required to develop a molecule into a clinically useful therapeutic entity. This is accomplished through the following:
Education and Communication:
Education on hot topics in regulatory sciences, both in clinical pharmacology and drug development. This includes discussion of influence and impact of clinical pharmacology, translational medicine, and regulatory science:
  • Present examples of clinical pharmacology that made a difference in drug development and usage.
  • High impact examples of modeling and simulation and impact on regulatory approvals and drug development decision making.
  • High impact examples of where systems pharmacology made a difference to the label.
  • How to translate information into a label (labeling associate director).
  • Outreach to global regulatory agencies to discuss key hot topic issues.
Collaboration:
Advance the scientific expertise in regulatory science by promoting collaboration between academic, industrial, and regulatory scientists including:
  • Key external groups
  • Key ASCPT groups
ASCPT 2019 Annual Meeting
Regulatory Science and Pharmacometrics and Pharmacokinetics Joint Community Meeting
Thursday, March 14 (7:00 am - 8:00 am)
Virginia Room
  • Community Introductions, Updates and Accomplishments
  • Featured speaker: Dr.  Shiew Mei Huang, US FDA, special presentation, “MIDD: Challenges, Opportunities, and Update” 
  • Brainstorming for 2020 Annual Meeting Program, Webinar programming 
  • Call for Community involvement and volunteers
Prior to the meeting, please use the following link to complete a brief survey to capture your suggestions for 2020 ASCPT program:  https://www.surveymonkey.com/r/ZRLSQXD

In addition, we are happy to announce that there will be 3 Regulatory Science and Pharmacometrics & Pharmacokinetics joint programs in this year’s Annual Meeting. Please mark your calendar and join us for these events!
  • SYMPOSIUM: Thursday, March 14th 2:30pm – 4:30pm
    How Artificial Intelligence and Machine Learning Techniques Are Revolutionizing Drug Discovery and Development
  • WORKSHOP: Friday, March 15th 10:30am – 12:00pm
    Geriatric Clinical Pharmacology: State of the Art in a Neglected Majority
  • NOVEL FORMAT: Saturday, March 16th 12:30pm – 2:00pm
    MID3: Mission Impossible or Model-Informed, Drug Discovery and Development? Point / Counterpoint Discussions on Key Challenges
Past Webinars
Community Announcement:
The 2017 NME report has been published. Click here to access the report.

Anuradha Ramamoorthy, PhD

Community Chair

 

Puneet Gaitonde, PhD

Community Vice Chair

 

Robin O'Connor-Semmes, RPh, PhD

Community Past Chair

 

Regulatory Science Community Steering Committee:
Gopichand Gottipati, PhD
Lakshmi Vasist, PharmD
Zhu Zhou, PhD
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