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Good Clinical Practices
  Lay person should fit criteria provided by ICMR norms,   February 01, 2017
  AV consent should be maintained by investigator for record,   January 04, 2017
  How long a participant should be monitored for AE/SAE?,   November 30, 2016
  In paediatric clinical studies EC should include paediatrician,   November 02, 2016
  In Indian regulations, there is no provision for alternative to face-to-face consent,   October 05, 2016
  Essential documents should be retained at least 2 years,   August 31, 2016
  CDSCO rules for SAE do not differentiate between trials, study,   August 03, 2016
  EC can't review study protocol without prior registration with CDSCO,   July 06, 2016
  DCGI approval required for trial of new topical formulation,   May 31, 2016
  Judgement of investigator is final on SAE/AE,   May 04, 2016
  DCGI approval not required for clinical trial of herbal products,   April 06, 2016
  Can pharmacologist conduct BA/BE/PK study in paediatrics?,   March 03, 2016
  For clinical studies in children investigator must be paediatrician,   February 03, 2016
  Adverse events to be documented and assessed by investigator,   January 06, 2016
  No regulatory requirement prescribed for trial of non-notified IVDs,   December 03, 2015
  Medical devices notified under D&C Act need import licence,   November 04, 2015
  For a new drug evaluation DCGI approval is required,   September 30, 2015
  Regarding use of source data template there is no regulation,   September 03, 2015
  CDSCO approval essential to conduct clinical study of a new drug,   August 06, 2015
  FDCs are classified in 4 categories with specific regulatory requirements,   July 02, 2015

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