FDAnews Announces — Obtaining Consent in International Clinical Trials: Key Considerations Webinar, Dec. 11, 2015

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More than 60 percent of clinical studies submitted to CDER contain data from foreign study sites. Researchers need to be aware of the cultural differences, legal and regulatory requirements — and international guidelines — dictating principles for obtaining informed consent.

Obtaining Consent in International Clinical Trials:
Key Considerations
Dec. 11, 2015 — 11:00 a.m. – 12:30 p.m. EST
http://www.fdanews.com/obtainingconsentintlct

More than 60 percent of clinical studies submitted to CDER contain data from foreign study sites.

Researchers need to be aware of the cultural differences, legal and regulatory requirements — and international guidelines — dictating principles for obtaining informed consent.

Get prepared to adapt global informed consent templates to local country requirements.

Mark the calendar for Dec. 11 when Kristen Henderson, legal director at Quintiles, will help attendees navigate the international informed consent landscape with practical advice about:

  •     Cultural differences
  •     Regulatory environment factors (Case Study — India’s requirement for Audio-Visual Consent)
  •     Patient Populations (e.g., Pediatric, Incapacitated, Vulnerable Subjects)
  •     e-Consent and other Data Protection/Confidentiality Considerations
  •     Data sharing initiatives

Register today to get prepared for conducting international clinical trials.

Who Will Benefit:

  •     Clinical project specialists
  •     Clinical research associates
  •     Compliance officers
  •     Consultants/service providers
  •     Executive management
  •     General/corporate counsel
  •     Regulatory/legislative affairs professionals
  •     Strategic planning and business development staff
  •     Study monitors
  •     Study research coordinators
  •     Study sponsors
  •     Training personnel

Meet the Instructor:
Kristen M. Henderson is a Legal Director specializing in regulatory affairs and privacy at Quintiles, the largest biopharmaceutical services provider in the world. For nearly a decade, Kristen has provided practical guidance to Quintiles’ employees and customers on legal-regulatory and privacy matters, principally in the context of international clinical research. Kristen serves as the subject matter expert on informed consent matters within Quintiles’ Office of General Counsel, as well as primary legal counsel for Quintiles’ Health Engagement and Communications team.

Webinar Details:
Obtaining Consent in International Clinical Trials:
Key Considerations
Dec. 11, 2015 — 11:00 a.m. – 12:30 p.m. EST
http://www.fdanews.com/obtainingconsentintlct

Tuition:
$287 per site

Easy Ways to Register:
Online:     http://www.fdanews.com/obtainingconsentintlct
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
FDANEWS
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