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CRA's Knowledge and Adaptability Required to Monitor Informed Consent Process in an Evolving Regulatory Environment
Program Code:
418
Date:
Thursday, June 27, 2013
Time:
10:45 AM to 12:15 PM
EST
CHAIR
:
I have a 15-year experience in Clinical Research and have worked in mutiple CROs in different possitions. I started as a CRA long ago and for the past 2 years I have been a Clinical Research Manager for RPS Colombia. I have had the opportunity to work in diferent latinamerican countries as well.
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SPEAKER
(S):
Michael A. Swit,
Esq, JD (SCHNON), Special Counsel,
Duane Morris, LLP, United States
Michael Swit has solved vital FDA legal issues since 1984. Before joining Duane Morris, he was: VP at The Weinberg Group; with 3 major FDA law firms, general counsel of Par Pharmaceutical; and CEO of FDANews.com. He graduated magna cum laude from Bowdoin College and got his law degree at Emory U.
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Maria del Pilar Torres, (SCHNON), Clinical Research Manager, RPS Colombia LTDA, Colombia
Description
The evolving regulatory environment in clinical trials challenges clinical research associates (CRAs) to efficiently monitor the Informed Consent process. Today most countries have incorporated ICH guidelines into their regulations, GCP is the global standard for clinical research, and some countries are developing their own regulatory requirements (for example, Honduras) and others with regulations are drafting stricter regulations (for example, Guatemala andCosta Rica). CRAs must be aware of all the local regulations requirements when monitoring informed consents in different countries in Latin America. Due to the evolving regulations, the continuous review, training and search for any updates to the ICH Guidelines and local regulations are needed for the team.