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03-12-2018 (Singapore)

P40084 A Practical Guide to Pharmacovigilance
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A Practical Guide to Pharmacovigilance

3 – 4 December 2018 | Mandarin Orchard Hotel, Singapore

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Team Savings: Register 2 Delegates & the 3rd Comes free!

overview

Key Learning Outcomes

  • The role of drug safety in the successful development and usage of a medicine to the benefit of patients
  • What safety-related questions need to be answered in early and late drug development
  • Tools, techniques, and methodologies used in drug safety evaluation
  • What frequent pitfalls related to drug safety considerations occur and why they can lead to discontinuation of drugs in development, label changes or even withdrawal of drugs from the market after launch
  • How changes in safety assessment could become part of a new drug development paradigm

Who Should Attend

  • Anyone responsible for Pharmacovigilance
  • CEOs, Directors, Heads of Departments, Managers of:
    • International Pharmacovigilance
    • Clinical managers
    • Medical and Regulatory Affairs

What past participants say about our Pharma courses

“Exercises were useful and trainer is knowledgeable”
~ Noor Aida Binti Jaafar, Head of Marketing & Specialty Care, CCM Pharmaceutical

“Case Studies and the workshop activities really helped a lot and more practical”
~ Praveen Kumar, Senior Manager, Pharmaniaga

“Informative & insightful. Had a chance to network and share discussion / cross learn from participants”
~ Chng Kien Peng, Executive Director, Xepa-Soul Pattinson (S) Pte Ltd

“The course is very relevant to my job. The case studies and the workshop activities really helped a lot and were practical.”
~ Avadhanula Yagna Praveen Kumar, Senior Manager Intellectual Property, Pharmaniaga BHD

“Very informative. It covers all scopes under the topics”
~ Norliza Binti Abdullah Zawawi, Legal Assistant Manager, Pharmaniaga Berhad

pricing

Packages Price
2 Day TrainingSGD $3495SGD $3295Early BirdEarly Bird

Early Bird Rate: Register and Pay on or before 29 September 2018

Register 2 Delegates & the 3rd attends FREE!
Group rate is based on normal rate of 2-day main conference package only.
For Group Registrations, email register@ibcasia.com.sg or call +65 6508 2401

 

  • Special Group Discount pricing is applicable to groups of 2 or more delegates from the same organisation registering for the same event, at the same time.
  • Fee stated is the discounted price PER DELEGATE. Only one discount applies – either the early bird rate OR the Special Group Discount.
  • All fees stated include luncheons, refreshments and complete set of documentation. It does not include the cost of accommodation and travel.
  • A 7% Goods & Services Tax (GST) is applicable to all Singapore based companies for Singapore venue.

trainer

DI Dr. Salma Michor

MBA, RAC, CMgr, FCMI

Agenda

DAY ONE

OVERVIEW OF PHARMACOVIGILANCE REPORTING

  • Basic principles of pharmacovigilance
  • Thalidomide 1957-1961
  • Thalidomide’s Impact on Regulations
  • History of Pharmacovigilance
  • Pharmacovigilance & drug safety

CLINICAL VS. POST-MARKETING – ADVERSE EVENTS

  • Pre-Marketed AEs
  • Post-Marketed AEs
  • Pre- and Post- marketing: Basic Differences
  • The Importance of Adverse Event Collection & Reporting

CASE STUDY – 1

TERMS, DEFINITIONS AND EXAMPLES FOR ADVERSE EVENT REPORTING

  • Pharmacovigilance Definitions and Common Acronyms
  • ICH Definition of Adverse Event
  • Examples of Adverse Events
  • ICH Definition of Adverse Drug Reaction – CLINICAL
  • ICH Definition of Adverse Drug Reaction – POST MARKETING
  • Suspected Unexpected Serious Adverse Reaction
  • Sources of ADRs

ADVERSE EVENT PROCESS FLOWS

  • SOPs and process flows
  • Who is responsible for what
  • The role of the QPPV

CASE STUDY – 2

DAY TWO

ASSESSING ADVERSE EVENT REPORTS

  • Definition of a Serious Adverse Event
  • Assessing Adverse Events, Seriousness: Life Threatening
  • Examples of Life Threatening Adverse Events
  • Seriousness: Disability, Medically Significant Events
  • Difficulty Assessing Relationship of AEs with Drug
  • Labelled vs. Listed

REPORTING ADVERSE EVENTS: TYPES, TIMELINES, RECEIVERS

  • General Types of Reports
  • Expedited Reporting – What to Report
  • Suspected Unexpected Serious Adverse Reaction
  • Expedited Reporting – What not to report
  • Reporting Timeframes for ICSRs, Reporting to IRB/ECs

GPVP – GLOBAL REGULATORY REQUIREMENTS

  • EU, EudraVigilance – Pre-Marketing Requirements, EudraVigilance – Post-Marketing Requirements
  • EUDRA CT Database
  • US, Reporting Requirements
  • Other regions

CASE STUDY – 3

THE PHARMACOVIGILANCE AUDIT

  • Audits & Inspections, Types of Audits & Inspections
  • Who Can be Audited?
  • Preparing for a Pharmacovigilance Inspection

SIGNALLING AND RISK ASSESSMENT

  • Signal Detection, The Cost of Failure
  • Risk Management Components
  • FDA Risk Management Components
  • EMA Signalling Requirement

CASE STUDY – 4

when & where

03 - 04 Dec 2018

Mandarin Orchard Singapore, by Meritus
333 Orchard Road, Singapore 238867
Tel: +65 6831 6062 | Fax: +65 6737 3130
Mobile No.: +65 8298 9442
Contact Person: Tan Ai Li
Email: aili.tan@meritushotels.com
Website: www.meritushotels.com

On-site & in-house training

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