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Dr Rajashree Devarakonda
General Manager and Director
Voisin Consulting Life Sciences
16 July 2013
to
Drug
and
122-DAB
122-DAC
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-
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122-DD
- Registration of ECs.
- Requirements & guidelines for EC registration
including application, composition, maintenance
of records etc.
Permission of CTs.
Approval of ECs before trial initiation.
Annual reports of CT status.
Ins pec tion of trial s ite and pers o n n e l b y
CDSCO to check compliance with Schedule Y
and GCPs etc.