THE COMPLIANCE

INTERNATIONAL CONFERENCE ON HARMONIZATION (ICH)
  • E2A - Clinical Safety Data Management: Definitions and Standards for Expedited Reporting
  • E2B(R3) - Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports
  • E2B(R3) IWG - Implementation: Electronic Transmission of Individual Case Safety Reports
  • E2C(R2) - Periodic Benefit-Risk Evaluation Report
  • >E2C(R2) - Q&As Questions & Answers: Periodic Benefit-Risk Evaluation Report
  • E2D - Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting
  • E2E - Pharmacovigilance Planning
  • E2F - Development Safety Update Report
  • >
GOOD PHARMACOVIGLANCE PRACTICES (GVP MODULES)
  • Module I – Pharmacovigilance systems and their quality systems
  • Module II – Pharmacovigilance system master file
  • Module III – Pharmacovigilance inspections
  • Module IV – Pharmacovigilance audits
  • Module V – Risk management systems
  • Module VI – Management and reporting of adverse reactions to medicinal products
  • Module VII – Periodic safety update report
  • Module VIII – Post-authorisation safety studies
  • Module VIII addendum I – Member States' requirements for transmission of information on non-interventional post-authorisation safety studies
  • Module IX – Signal management
  • Module X – Additional monitoring
  • Module XV – Safety communication
  • Module XVI – Risk minimisation measures - Selection of tools and effectiveness indicators
FOOD & DRUG ADMINISTRATION (21 CFR Part 11)

  • Subpart A--General Provisions
  • § 11.1 - Scope.
    § 11.2 - Implementation.
    § 11.3 - Definitions.
  • Subpart B--Electronic Records
  • § 11.10 - Controls for closed systems.
    § 11.30 - Controls for open systems.
    § 11.50 - Signature manifestations.
    § 11.70 - Signature/record linking.
  • Subpart C--Electronic Signatures
  • § 11.100 - General requirements.
    § 11.200 - Electronic signature components and controls.
    § 11.300 - Controls for identification codes/passwords.

CENTRAL DRUG STANDARD CONTROL ORGANIZATION (CDSCO)

  • SCHEDULE Y

COUNCIL FOR INTERNATIONAL ORGANIZATIONS OF MEDICAL SCIENCES (CIOMS)

  • CIOMS Working Group I - International Reporting of Adverse Drug Reactions
  • CIOMS Working Group II - International Reporting of Periodic Drug-Safety Update Summaries
  • CIOMS Working Group III - Guidelines for Preparing Core Clinical-Safety Information on Drugs
  • CIOMS Working Group IV - Benefit-Risk Balance for Marketed Drugs: Evaluating Safety Signals
  • CIOMS Working Groups V - Current Challenges in Pharmacovigilance: Pragmatic Approaches

Untitled Document

For Enquiry

Please do not send any Job Applications/Queries through this form

Contact Us

Address: HAROM Solutions
SCO 117-118, Level I
Sector 17B Madhya Marg
Chandigarh-160017
Phone No:- +91 172-4663037 , 9988756469
E-mail: info@haromsolutions.com
Contact us

Contact us for help, additional info or assistance and we'll be with you in no time!

Enter your name
Enter your email
Your message