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Tuesday, June 21 • 11:00am - 12:00pm
#221: Complying with the EU-CTR Disclosure Standards in the Era of GDPR

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-557-L04-P ; CME 1.00; RN 1.00

Hear from disclosure experts about their organizations’ approaches to EU-CTR disclosure requirements while complying with GDPR and how EU-CTR disclosure compares with EMA CDP (EMA Policy 0070) disclosure.

Learning Objectives

Identify the disclosure requirements and standards as written in the European Union (EU) – Clinical Trial Regulation (CTR); Evaluate how the disclosure standards for EU-CTR align with the requirements of the EU General Data Publication (GDPR); Describe how the disclosure standards in the EU-CTR compare to the standards of the Clinical Data Publication (CDP; aka EMA Policy 0070).

Chair

Robin Whitsell

Speaker

Preparing for EUCTR
Lora Killian, MBA

Influences in Transparency Approach for EU CTIS
Julie G. Holtzople

Lessons Learned for EU CTIS Submissions
Wendy M Wimmer, MS


Speakers
avatar for Julie Holtzople

Julie Holtzople

Senior Director Clinical Transparency and Data Sharing, AstraZeneca, United States
Julie Holtzople is the Sr. Director of Clinical Transparency & Data Sharing for AstraZeneca and co-lead of the CREG CTT group. Julie received her Bachelors of Science in Business Administration at Virginia Polytechnic Institute. Julie has been with AstraZeneca for 14 years. Prior... Read More →
avatar for Lora Killian

Lora Killian

Clinical Trial Transparency and Disclosure Lead, Pfizer Inc, United States
Lora has 20+ years of business experience, including more than a decade of pharmaceutical industry experience. She started her career in the military serving four years of active duty in the Medical Service Corp for the U.S. Army. In her first pharmaceutical industry position, Lora... Read More →
avatar for Wendy Wimmer

Wendy Wimmer

Director, Clinical Data Disclosure and Transparency, Merck & Co., Inc., United States
Wendy Wimmer is a Director in the Clinical Data Disclosure & Transparency department at Merck Sharp & Dohme. She has over 25 years of clinical research experience and over the last 6 years has created and currently manages a centralized document transparency functional area for her... Read More →

Tuesday June 21, 2022 11:00am - 12:00pm CDT
Room 470 B McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  04: MedAffairs-SciComm, Session |   08: RD Quality-Compliance, Session |   09: Regulatory, Session