Indian Society of Clinical Research (ISCR), Western Chapter
South Asian Chapter of American College of Clinical Pharmacology (SAC-ACCP)
Second Clinical Research Case Discussion Meeting
“Case controversy related to Informed Consent, Safety and other issues in clinical investigation ”
Meeting Date: 1530-1700 hrs forward 24th July 2015; Friday
Venue: JMLT, Seth GS Medical College& KEM Hospital, Parel, Mumbai
Introduction: Issues connected to Placebo controlled studies, informed accord and safety reporting are discussed and debated amongst the clinical careful search community and has several nuances that needs to be kept in re~ by all stakeholders based on the changing regulations in India.
In the current regulatory meteorological character, the investigator, EC member and godfather need to be aware of guidelines/regulations in the manner that applicable in such complex scenarios. Often the P.I and the site coordinator require hand holding by the CRA/Medical Monitor to render certain that the patient is managed in the manner that per the protocol but in agreement with changed regulations.
The case debating will try to throw light up~ the body the different facets of recent clinical assay guidance and regulations from the view of clinical research/operations professional, Investigator, ethics committee, medical monitor and Sponsor/CRO.
Target Audience: Clinical Research, Medical Affairs, Regulatory Affairs professionals, Ethics committee members, and Investigators.
Faculty: To have ~ing announced soon
Organizer cum RSVP: Dr Sanish Davis, Medical Director, Covance. firstname.lastname@example.org Direct: 022-6179 3945 Cell : 750 665 3426 / 9820958943
# There is no memorandum fee. Please come and be seated put ~ time so that you do not derange others who are on time. Seating determine be on first come basis.
# Please have currency this invite widely to members not above your organization so that they can benefit!
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