The Arab Pharmacovigilance Guidelines (Dubai, United Arab Emirates - October 22-23, 2018)

  • ID: 4592397
  • Conference
  • Location: Dubai, United Arab Emirates
  • 2 Days
  • Management Forum
  • Conference Dates: October 22-23, 2018
OFF
until Aug 24th 2018
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There are fundamental changes to pharmacovigilance practice described in these guidelines which follow the EU guidelines, issued and implemented in June 2012. This intensive two-day course will look at the various new topics and their practical application.

Course overview

The new Arab pharmacovigilance guidelines were issued in May 2015 with their introduction on 1 July 2015. There are fundamental changes to pharmacovigilance practice described in these guidelines which follow the EU guidelines, issued and implemented in June 2012. This intensive two-day course will look at the various new topics and their practical application from the perspective of the introduction of the EU guidelines. The course will include experiences of inspections and audits following implementation and will identify what the main focus points will be.

Please note, events may be cancelled due to commercial or organisational reasons. In this case Research and Markets will refund all registration fees which have already been paid. Research and Markets will not refund any charges arising from the participant having to cancel or re-book transportation or accommodation which he or she has arranged.

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Programme - Day One

An Introduction to the new PV Structure

  • The new modules
  • The interaction of the modules - A comparison to the EU modules

Module I – Quality management systems

  • Quality control, quality assurance, and quality management
  • Quality management of PV systems
  • The QP PV and quality management
  • Quality and training
  • QA and quality management and internal audits

The Pharmacovigilance Systems Master File (PSMF – Module II)

  • The content of the PV master le
  • Licence submissions and the PV master le
  • The QP PV and the PV master le
  • Control/management of the PV master le

Pharmacovigilance inspections (Module III)

  • The purpose of the inspection
  • Types of inspection
  • Inspection ndings
  • Re-inspections

Pharmacovigilance audits (Module IV)

  • The purpose of company audits
  • Audit scheduling and risk
  • Audit outputs and ndings
  • Audit findings and their corrections – root cause analysis, corrective action plans, completion and re-audits

Programme - Day Two

Risk Management Plans (RMPs – Module V)

  • ICH E2E – pharmacovigilance planning
  • The RMP purpose
  • The RMP format
  • Updating the RMP
  • RMPs and REMs

MODULE VI – Adverse Reaction Reporting - Part 1

  • De nitions
  • Special situations
  • Triage – seriousness
  • Expectedness and causality
  • Expedited reporting

MODULE VI – Adverse Reaction Reporting - Part 2

  • Electronic ADR reporting local and International
  • Follow up of cases
  • ICH E2D – post marketing safety
  • Literature ADR reporting
  • Case closure

PSURs/Module VII

  • ICH E2F and ICH E2C (R2) – DSRRs and PSURs/PBRERs
  • Objectives of the PSURs
  • Risk benefit analyses in PSURs
  • The format of the PSUR
  • Mapping Signals and Risks to the PSUR

Signals and their management (Module IX)

  • What is a signal?
  • Signal validation
  • Signal analysis and prioritisation
  • Signal assessment
  • Actions to be taken
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Graeme Ladds

Graeme Ladds, Director of PharSafer, has over 30 years’ experience working in the pharmaceutical industry. Having started his career at Ashbourne Pharmaceuticals in 1989 as Head of Drug Safety & Medical Information, he went on to become Head of Global Pharmacovigilance at Shire Pharmaceuticals. He then set up his consultancy and specialist CRO company, PharSafer Associates Ltd, where he has been involved in establishing pharmacovigilance in companies, performing audits across Europe and the USA, SOP writing, acting as QP for companies, and helping with regulatory inspections.

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Anyone involved in pharmacovigilance and regulatory activities, including pharmacovigilance case processing; local QP PVs; medical directors; drug safety managers; QA auditing; PSUR writers and any company managers and licence holders wanting to know what impact this will have on their business practices.

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ADDRESS

Raffles Dubai Hotel
Sheikh Rashid Road
Wafi - PO Box 121800
Dubai
United Arab Emirates


DIRECTIONS

Raffles Dubai occupies a pre-eminent position right on Sheikh Rashid Road, the premium business and shopping district located in the heart of Dubai.

  • 15 minutes from Dubai International Airport
  • 5 minutes from Dubai business district and Dubai International Financial Centre
  • Minutes from Dubai’s tourist attractions and renowned Burj Khalifa
  • Connected to WAFI
  • Easy access to the Dubai Metro station

Getting Here

The easiest way to get to the hotel from the airport is by taxi. There are plenty of taxis available and the hotel is only 15 minutes away. You can also ask us to arrange transfers to and from the hotel at an extra cost. Alternatively you can jump on the Dubai Metro – although there are luggage restrictions – from Dubai International Airport and get off at the Dubai Healthcare City station, a short 2 minute walk to the hotel.

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