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India Seminar 2012 at Mumbai
GlobalCompliancePanel proudly presents its next India Seminar on
USFDA & EU Essentials of Drug Safety and Pharmacovigilance
Overview
Product safety makes headlines every day - and the impact Steve Jolley
on a company’s image, consumer confidence, and Wall Principal, SJ Pharma Consulting
Street’s opinion is profound. While good safety data has Steve Jolley is a subject matter expert in
historically been a prerequisite for product approval, recent all areas of global safety compliance and
media attention has intensified public and Congressional
signal detection, and is a frequent
scrutiny and resulted in regulations such as the FDA
speaker at leading industry events
Amendment Act and its strengthened requirements for
including DIA and MHRA. He has 25
monitoring post-marketing safety.
years’ experience in drug safety & pharmacovigilance and
has worked with over 50 clients in the US, Europe and
This training course is designed to give pharmaceutical and
Japan. He holds degrees in mathematics and computer
biologic companies operating in the U.S. and EU an
science from Cambridge University, England. Steve is a
understanding of product safety and regulatory compliance. featured speaker with FDA at DIA conferences and webinars
The course will include case studies of adverse events to on auditing, signaling and data mining.
illustrate the decision-making process and reasoning
needed behind when and how to properly report incidents to Steve began his career in the pharmaceutical industry in
regulatory authorities. 1985 when he founded DLB Systems, a supplier of computer
systems for clinical trials and adverse event reporting to
Download Brochure many of the leading life science companies worldwide.
Date and Venue more...
March 5th, 6th and 7th, 2012
at Mumbai, INDIA Download Registration Form
Hotel: TBD
For Sponsorship
Agenda Conference timings: 9:00 am - 6:00 pm
Day 1 - 5th March 2012 Day 2 - 6th March 2012 Day 3 - 7th March 2012
Overview of Pharmacovigilance: (90 Background to Signal Detection: (90
Inspections and Audits: (90 minutes)
minutes) minutes)
l History of Pharmacovigilance l Audits vs Inspections l The need for signal detection
l Pre-Marketed AEs l Why Conduct Them? l Regulatory Requirements
l Post-Marketed AEs l Types of Audits & Inspections l Approach to Signal Detection
l Pre- and Post-marketing: Basic l Who Can be Audited? l Company Characterization
Differences l Approaches l Characteristics of small versus
l The Importance of Adverse Event l Preparing for a Pharmacovigilance large companies
Reporting Inspection l Premise for Signal Detection
l Pharmacovigilance Definitions Pharmacovigilance Best Practices: l Importance of astute clinical
l ICH Definition of Adverse Event (90 minutes) perspective
l ICH Definition of Adverse Drug Reaction l Danger of over-reliance on
l Achieving Best Practices through
l Suspected Unexpected Serious the Pharmacovigilance Audit technology
Adverse Reaction l Signal Detection Hierarchy
l Value Derived
l Sources of ADRs l Layered approach to signaling
l Scope
l Pharmacovigilance Process l Statistical versus medical
l Pharmacovigilance Process Model
l Audit Items - Collection
significance
Assessing Adverse Event Cases: (90 l Audit Items - Assessment Signalling Exercises: (90 minutes)
minutes) l Audit Items - Reporting
l Assessing Adverse Events l Audit Items - Analysis l Signaling Case Study
l Regulatory Definition of a Serious l Additional Audit Items (1) l Data Flow
Adverse Event l Additional Audit Items (2) l Recommended data elements to
l Severity/Intensity l Company Sources of Information to be obtained prior to analysis
l Difficulty Assessing Relationship of AEs be Examined l Typical PSUR data elements
with Drug l PV Checklist l Analysis by MedDRA System
l Causality Preparing for an Inspection: (90 Organ Class
l Lack of Efficacy -- ICH minutes) l Analysis by MedDRA Preferred
l Expectedness Term
l Pharmacovigilance Risk Profile
l Assessing l Analysis by Age Range
l Priority of Findings
Expectedness/Labeledness/Listedness l Report Table of Contents
l Analysis by Sex
l Labeled vs. Listed l Analysis by Country
l Limited Diagnostic Can Initiate The
Assessment l Analysis by Time to Onset
Reporting Adverse Events:(90 minutes)
l Analysis by Treatment Duration
l Assessment Approach
l General Types of Reports l Workflow/Processes - Global Data Mining Exercises: (90 minutes)
l Expedited Reporting - What to Report l Processes - CRO
l Validation Protocols l Data Assessment l What is Data Mining?
l Aggregate Reports – Common Types l Personnel Qualifications & Training l Principles of Safety Data Mining
l Reporting Timeframes for ICSRs Case Studies with Real-Life Inspection l Data Mining Fundamentals
l Reporting to IRB/ECs Findings: (90 minutes)
l Minimum Criteria for Reporting Pharmacovigilance and Risk
Minimum Data Set – Day “0” l Representative Findings from Case Management Process: (90 minutes)
l
l Reporting Format Study
l Pharmacovigilance Process
l Four Case Studies
Global Regulatory Requirements: (90 l Signal Detection Operational
l Critical Issues Observed
minutes) Questions
l Major Issues Observed
l Signal Detection Sources
l Tips for the Pharmacovigilance
l Matrix of Safety Regulations l Signaling Process
Audit
l New FDA Regulation for IND safety l Signal Evaluation Steps
l Eight Domains of PhV
reporting l Signal Repository and Safety
l Inspection Findings
l International Conference on Profiles
l How to Address Inspection
Harmonisation (ICH) l Product Safety Profile (PSP)*
Findings?
l ICH Topic Codes and Reports l Risk Management Planning
l Eudravigilance - Post-Marketing l Factors to Consider in Signaling
Requirements Optimization
l IND Annual Report l Signal Detection Triage Example
l New European Pharmacovigilance l Triage Algorithms Used
Legislation l Comprehensive Signaling
Process Elements
Pricing List
Contact Information:
Event-coordinator
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Phone number: +91 80-3221-3341 /
+91 80-3247-3696 / +91 80-3221- Between January 30th to February 18,000 2,000
3329. 18th
Fax number: +91 80-2642-1483
Between February 19th to March 4th 20,000 0
Email:
customersupport@globalcompliancepanel.com
GlobalCompliancePanel
We will be able to accommodate limited number of attendees so if you and your
C/O NetZealous Services India Pvt. Ltd.
colleagues would like to attend this training seminar, call us today at +91 80-
4th Floor, A, Block, Brigade Software
Park, Banashankari 2nd stage, 3221-3341 / +91 80-3247-3696 / +91 80-3221-3329 to reserve your seat.
Bangalore-560070. INDIA
Download the Registration Form
Best regards,
Team
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