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Community-led-Scientific Working Group Offerings [clear filter]
Monday, June 27

1:30pm EDT

#149: EMA's Publication Policy 0070: Best Practices for Implementation
Limited Capacity seats available

Component Type: Workshop
Level: Intermediate

In this session, we will share experiences and discuss best practices and solutions to challenges that sponsors are facing with EMA Policy 0070. EMA has provided general guidance but has not been prescriptive. They have also emphasized that this will be a learning process for both EMA and industry with an opportunity to provide feedback along the way. In this session, there will be a brief overview, followed by break-out discussions in small groups. Questions to be discussed include:

• What steps are sponsors taking to ensure that their approach and rationale are consistent from document to document? How may this feedback be shared with EMA to ensure consistency in what is accepted?

• How are companies approaching the anonymization of case narratives?

• How can organizations best write documents bearing in mind downstream CCI and patient de-identifying redaction (without using expensive vendors)? How are organizations managing their internal governance?

• How are companies handling the review of Informed Consent Forms for ‘older’ CSRs that are in scope of Policy 0070?

**Due to session format, seating will be limited to 50 participants and available on a first come, first served basis. Once all seats are occupied, DIA will be required to close the session, and no more participants will be admitted. Interested attendees are encouraged to arrive early in order to ensure seating.

Learning Objectives

Describe steps sponsors are taking to ensure their approach and rationale are consistent from document to document; Identify approaches sponsors are using to anonymize case narratives; Discuss how companies are handing the review of Informed Consent Forms for legacy clinical trials.


Robert Paarlberg, MS


Helle M Gawrylewski, MA

avatar for Robert Paarlberg

Robert Paarlberg

Principal, Paarlberg & Associates LLC, United States
Robert Paarlberg is 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 worked at Pharmacia (Upjohn) and UCB... Read More →

avatar for Helle Gawrylewski

Helle Gawrylewski

Senior Director, Medical Writing and Alliance Management, Janssen Research & Development, LLC
Head Med Affairs Writing/ MW Alliances, previously director of Early Development and multiple therapeutic area writing at J&J for 17yrs. 2-term MW SIAC Chair, and CDISC Protocol Rep/Glossary Group from 2001. Held positions of increasing responsibility in MW and management for 40... Read More →

Monday June 27, 2016 1:30pm - 2:15pm EDT
Exhibit Hall A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 22: Engage and Exchange, Workshop