Global Pharmacovigilance - Best Practices /  + Drug Safety Surveillance Workshop (Complementary)

Global Pharmacovigilance - Best Practices / + Drug Safety Surveillance Workshop (Complementary)

 

  • GLOBAL PHARMACOVIGILANCE AND DRUG SAFETY WORKSHOP

    Pharmacovigilance

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    INR 14000
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About The Event

 

GLOBAL PHARMACOVIGILANCE - Best Practices & DRUG SAFETY - Worshop for students & working professionals 

 

WHO SHOULD ATTEND

 

  • Drug Safety Professionals currently working in Pharmaceutical Industry
  • Pharmacovigilance Staff currently working at CROs
  • Medical Doctors, Nurses and Licensed Pharmacists
  • Clinical Development Staff/ Professors/ Lecturers 
  • Regulatory Affairs Professionals 
  • Students- Medical/ Paramedical

 

 

WORKSHOP DESCRIPTION:  The objectives of this workshop will be global drug safety and starts with delivery of an introduction to the basics of drug safety and pharmacovigilance, including regulatory requirements, adverse event reporting, signaling and risk management. This course addresses the regulatory issues across global government agencies that improve safety, but slow down the product approval process. Keeping products on the market without interruption becomes more essential with the reduced pipeline of drugs in development. Successful navigation of drug safety and pharmacovigilance are keys to product longevity, consumer confidence, and regulatory compliance. This course will provide learners with the regulatory references, processes, best practices, and analysis and investigation techniques to minimize risk, avoid product recall, and meet international (FDA/EMEA/DCGI) safety and reporting standards.

 

SPEAKERS:  Eminent Clinical Pharmacologists, Drug Safety Experts and Drug Regultory Authorities as well as Head of PV Units 

 

LEARNING OBJECTIVES: 

  • Work to international standards by meeting regulatory requirements for product safety 
  • Perform signaling and risk management functions 
  • Collect, assess, report, and analyze adverse events 
  • Create signaling analyses based on FDA / Country-specific Good Pharmacovigilance Practices 
  • Identify differences between US, European and Asian drug regulatory and legal requirements

 

WORKSHOP SCHEDULE OUTLINE

 

Day 1:   10:00 a.m. – 3:00 p.m. 

 

  • Overview of Pharmacovigilance: Thalidomideand History of Pharmacovigilance; Limitations of Pre-approval Clinical Trials; Post-Marketed AEs; Pharmacovigilance Definitions; Assessing Adverse Events; Serious vs. Severe; Causality; Expectedness; SUSAR; Minimum Criteria for Reporting; Reporting Format; Managing Blinded Therapy Cases; Sponsor Responsibilities; Monitor Responsibilities; Principal Investigator Responsibilities; Adverse Reaction Types; Safety Signal Generation 

 

Day 2:   10:00 a.m. – 3:00 p.m

 

  • Pharmacovigilance Compliance: Matrix of Safety Regulations; International Conference on Harmonisation (ICH); CIOMS; Key EU Components; EU Member States; Eudravigilance; EU Clinical Trial
    Directive; Volume 10; Volume 9A; European Signaling Regulations; ASR, IND, DSUR reports
  • PV Audits - Preparing for a Pharmacovigilance Audit; Achieving Best Practices; Scope; PV Checklist; Case Studies; Eight Domains of PhV; Key Findings by MHRA; Quiz on Regulations & Compliance
  • Signaling & Risk Assessment: Need for Signal Detection; the Cost of Failure; Regulatory Requirements for Signaling; EMEA Signaling Legislation; MHRA & Signal Detection; Approach to Signal Detection; Sample Signaling Analyses; Methodologies: MGPS, BCPNN, PRR; Signaling Process; Product Safety Profile; Risk Management Planning; Quick Quiz for Signaling
  • INTERACTIVE AND SNACK SESSION

 

  • Signaling Exercises: Analysis of PSUR data by MedDRA System Organ Class, Preferred Term, Age Range, Sex, Country, Time to Onset, and Concomitant Medications 
  • Quiz on "The Pharmacovigilance Audit"

 

 

Registration fees include assorted breakfast items that will be available each day ½ hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day. 

 

Special rates are available for multiple attendees from the same organization.  Contact Ms. Keerti Kamath for questions at:  keerti.kamath89@gmail.com  and/or at:  91-9581634185 to discuss your options and take advantage of the savings.

 

CERTIFICATE OF PARTICIPATION & APPRECIATION SHALL BE PROVIDED UPON ATTENDING THIS WORKSHOP