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Wednesday, June 27 • 10:30am - 12:00pm
#334: Clinical Trial Disclosure: Learnings from EMA Policy 0070, NIH Final Rule, and FDA’s Clinical Data Summary Pilot Program

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Component Type: Session
Level: Intermediate
CE: ACPE 1.50 Knowledge UAN: 0286-0000-18-643-L04-P; CME 1.50; IACET 1.50; RN 1.50

Identify key areas impacted by Policy 0070 and the NIH Final Rule, challenges and approaches for compliance; Describe experiences with redaction packages; Discuss how companies are approaching EMA, ClinicalTrials.gov and FDA’s new pilot clinical document requirements and identify best practices.

Learning Objectives

Identify key areas impacted by Policy 0070 and the NIH Final Rule, challenges and approaches for compliance; Describe experiences with redaction packages; Discuss how companies are approaching EMA, ClinicalTrials.gov and FDA’s new pilot clinical document requirements and identify best practices.

Chair

Robert Paarlberg, MS

Speaker

The Evolution of Clinical Data Transparency: Streamlined Project Management in the EMA’s Policy 0070 Space
Rosalynd Cole

Disclosing Data: EMA Policies 0043/0070, EudraCT, and the Clinical Trial Regulation - Where Are We Now?
Maria Isabel Manley, LLM

Update from ClinicalTrials.gov
Rebecca J. Williams

Beyond Disclosure: Working Toward Better Outcomes for Patients
Olivia Shopshear, MS

FDA’s Pilot to Enhance Transparency of Clinical Trial Information
Ann M. Witt, JD

EMA Update
Anne-Sophie Henry-Eude, PharmD


Speakers
avatar for Rosalynd Cole

Rosalynd Cole

Accenture UK Ltd
Rosalynd Cole is a Senior Manager in Jazz Pharmaceuticals’ Project Management Office in the UK. With a background in pharmaceutical Regulatory Affairs established by  working in the trifecta of big pharma, generics and a leading consultancy, Roz has developed a range of expertise... Read More →
avatar for Anne-Sophie Henry-Eude

Anne-Sophie Henry-Eude

Head of Documents Access and Publication Service, European Medicines Agency (EMA)
Anne-Sophie Henry-Eude is a doctor in pharmacy with post-graduate degrees in Regulatory Affairs and Pharmacovigilance & Pharmacoepidemiology. She worked in the pharma industry then joined EMA as product team leader for anti-infectives. She then worked on paediatric investigation plans... Read More →
avatar for Maria Manley

Maria Manley

Partner, Head of the UK Life Sciences, Sidley Austin LLP
Marie advises on a broad spectrum of matters, both contentious and non-contentious, that arise in the conduct of a bio pharmaceutical business. Marie represents pharma companies before UK and EU institutions (EMA, MHRA, NICE, PMCPA DOH and the European Commission). Marie is Chairperson... Read More →
avatar for Robert Paarlberg

Robert Paarlberg

Principal, Paarlberg & Associates LLC
Robert Paarlberg is the Principal of Paarlberg & Associates LLC, a consultancy specializing in regulatory policy, regulatory intelligence and global clinical trial disclosure strategy and operations. Prior to founding Paarlberg & Associates LLC, Bob created and directed global regulatory... Read More →
OS

Olivia Shopshear

Senior Director, Science and Regulatory Advocacy, PhRMA
Olivia is a senior director of Science and Regulatory Advocacy at the Pharmaceutical Research and Manufacturers of America (PhRMA). Olivia has extensive multi-disciplinary program management and policy experience in the biopharmaceutical and biodefense industries, ranging from pre-clinical... Read More →
avatar for Rebecca Williams

Rebecca Williams

Assistant Director, ClinicalTrials.gov, NCBI, National Institutes of Health (NIH)
Rebecca Williams, PharmD, MPH, is Assistant Director, ClinicalTrials.gov at the National Library of Medicine, National Institutes of Health. In this role, she oversees the results submission process, outreach and education, policy development, and conducts research. Her prior experience... Read More →
AW

Ann Witt

Counselor to DC for Policy, OND, CDER, FDA
Received my BA from Bryn Mawr College, and JD from Stanford Law School. After 1-year clerkship, came to work at FDA in 1980. Worked in the Office of Chief Counsel on new drug issues and the Office of the Commissioner until 2002, when I did an 8-year stint on Capitol Hill. Returned... Read More →

Wednesday June 27, 2018 10:30am - 12:00pm
Room 210C Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  04: MedAffairs-SciComm, Session