Cliniminds Network: India | US | UK | Saudi Arabia | Philippines

Email us @ kshahani@cliniminds.com; M : +91 98100 68241

CLINIMINDS PHARMACOVIGILANCE TRAINING SOLUTIONS FOR PHARMACEUTICAL, MEDICAL

DEVICES, VACCINE COMPANIES AND CROs

Cliniminds offer wide corporate training solutions in Pharmacovigilance for the pharmaceutical,
medical device, vaccine companies and CROs. Programs could be customised to the needs of the
organisation. Programs could be offered onsite globally, through Cliniminds LMS using
WeBex/GoToMeeting, includes PowerPoint presentations, notes, evaluation and combination of
programs delivery options in different geographies globally.

Cliniminds Pharmacovigilance Learning System

 Learning Management System (LMS) platform 21 CFR Part 11 compliant

 Original Content in English. Translations of training content available in Japanese, German,
French, Spanish, Mandarin or any other
 Live Webinar Sessions using WebEx / GoToMeeting and Recorded Sessions or Onsite
Instructor Led Training Programs
 Content with PowerPoint presentations, notes & audios
 Electronic employee training records for audits and inspections
 Customised Training Platform for organisation with your logo with secured access
 Admin Panel
 Secure password control access for all program participants
 Content updated annually and for any changes in regulations
 Online evaluation with multiple choice questions
 Client MIS
 Online & printed certificates
 Pricing – various flexible options from number of participants to annual licensing

Key Programs Offered by Cliniminds Pharmacovigilance are :

ICH Guidance - Basic Rules and concepts for:

 ICSR case processing and regulatory reporting

 RMP
 PBRER/PADER/DSUR/PSUR/Aggregate reports
 Signal management
 Risk communication

EUGVP

 module 1: Pharmacovigilance systems and their quality systems

 module 2: Pharmacovigilance system master file
 module 3: Pharmacovigilance inspections
 module 4: Pharmacovigilance audits
 module 5: Risk management systems

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 module 6: Collection, management and submission of reports of suspected adverse reactions to
medicinal products
 module 7: Periodic safety update report
 module 8: Post-authorisation safety studies
 module 9: Signal management
 module 10: Additional monitoring
 module 15: Safety Communication
 module 16: Risk minimization measures

Country Specific Safety Vigilance Regulation

 US
 EMEA
 Japan
 Other countries – Australia, Canada, India, MENA Region, U.K., China & India

Pharmacovigilance Introduction, Definitions

 An Overview of Pharmacovigilance
 Standard Definitions
 Similarities & Differences between Pharmacovigilance for Post Marketing Surveillance vs
Clinical Trials

Documents in Pharmacovigilance

 Reference Safety Information (RSI)

 Work Instructions (WI)
 Safety Data Exchange Agreements
 Pharmacovigilance System Master File (PSMF)

Safety Reporting and Processing ICSR

 Reportability Criteria & Case Reconciliation

 Case creation and Argus Data Entry
 MedDRA Coding
 Special Situations
 Narrative writing
 Medical Evaluation of ICSR
 Literature Search
 Understanding E2B (R3) and Medical Literature Monitoring

Aggregate Reports, Signal detection & Risk Management

 Aggregate Reports (PBRER, PSUR, PADER, DSUR)

 Signal Detection & Evaluation
 Risk Management / Risk Communication

Pharmacovigilance Regulations

 Pharmacovigilance Global Regulations emphasis on Europe, US, Japan, India

 21 CFR Part 11
 Council for International Organizations of Medical Sciences (CIOMS)

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  Good Pharmacovigilance Practice (GVP)
 ICH Guidelines for Pharmacovigilance

Hands on Training on Case Processing & Medical Information

 Introduction to Adverse event Probing, Filing PQC & Medical Information

 Routing Cases, Workflow management & Query Module
 Data Entry on Pharmacovigilance Database
 Writing Contact Logs and scheduling Action Items
 Extracting Line Listings & Summary Tabulations

Quality, Audits & Inspections

 Pharmacovigilance Quality Assurance

 Audits & Inspections Readiness
 CAPA
 Standard Operating Procedures (SOPs)

Advanced Pharmacovigilance, Analytics & Miscellaneous

 Data Mining and Social Media Analytics in Pharmacovigilance

 Eudravigilance and FAERS
 Vaccine Safety
 Safety in Medical Devices ISO9001 Basic concepts
 Epidemiology (Epidemiologic approach, Basis of epidemiology)
 21 CFR Part 11 Compliance

For more information, please call +91 98100 68241 or mail us at kshahani@cliniminds.com

Cliniminds Network : India | US | UK | Saudi Arabia | Philippines

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