FORUM INSTITUT
FORUM · Institut für Management GmbH
Vangerowstraße 18
69115 Heidelberg
Email: service@forum-institut.de
Phone: +49 6221 500-500
Fax: +49 6221 500-505

1) Introduction to pharmacovigilance - EU

  • History of drug safety
  • Why pharmacovigilance?
  • Important definitions
  • Desired vs. adverse reaction
  • Important elements of a modern PV system

 Dr Tanja Peters

Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim

Head PV Intelligence & Deputy EU-QPPV

2) Pharmacovigilance system master file (PSMF)

  • GVP Module II - Regulatory background
  • Format and content
  • Maintenance at a glance
  • National peculiarities and PSSF

Dr Axel Thiele

After more than 35 years in the pharmacovigilance department at the German competent authority BfArM responsible for referral procedures and the introduction of pharmacovigilance inspections, Axel is now a PV consultant and auditor. He is also assistant lecturer at a number of German universities.

3) Drug adverse reactions 

  • Sources of drug adverse reactions
  • Causality and benefit-risk assessment
  • Reporting timelines in Europe vs. reporting timelines in Middle East
  • Special cases (off-label use, overdosage, etc.)
  • MedDRA, a short overview

 Dr Reinhard Nibler

Dr Nibler and Partner, Munich
 
Consultant

4) Signal management

  • Signal – An intuitive concept in a regulated framework
  • Signal stages: detection, validation, confirmation, analysis, assessment
  • Statistical and qualitative methods
  • Data collection, decision making and communication
  • Process implications for the MAH

Dr Ulrich Vogel

Boehringer Ingelheim International GmbH, Ingelheim
 
Head Strategic Data Analysis, Global Pharmacovigilance

5) Risk management plan

  • Scope
  • Important definition
  • Structure
  • Content
  • Interference with other pharmacovigilance documents

 Sven Schirp

Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim
 
Head of Global Pharmacovigilance Writing

6) Risk management system

  • Risk minimisation measures and performance measuring
  • Risk communication (DHPC letter, etc.)
  • Post-authorisation safety studies (PASS)
 
Dr Angela van der Salm
DADA Consultancy, Netherlands
 
Director Pharmacovigilance, Managing partner
 
In addition to her role as director of the pharmacovigilance department at DADA, Angela also functions as QPPV for several clients, and is the first point of contact for pharmacovigilance enquiries. Angela joined DADA in 2010 and set up the pharmacovigilance department. She holds a PhD in life sciences and previously worked in pharmacovigilance at generic and innovator companies in the pharmaceutical industry.

7) Periodic safety update reports (PSUR)

  • For which products are PSURs mandatory?
  • Interval, data lock points and period
  • PSUR format and content
  • Interference with other pharmacovigilance documents
  • How to gather and evaluate data for PSURs

 Sven Schirp

Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim
 
Head of Global Pharmacovigilance Writing

8) Pharmacovigilance inspection and audit readiness

  • Fundamentals of inspections and audits: regulations, occurrence, types and aims
  • Strategic planning and preparation - pitfalls
  • Communication with the inspector/auditor
  • Report, typical findings and follow-up measures

Dr Axel Thiele

After more than 35 years in the pharmacovigilance department at the German competent authority BfArM responsible for referral procedures and the introduction of pharmacovigilance inspections, Axel is now a PV consultant and auditor. He is also assistant lecturer at a number of German universities.

9) Qualified person for pharmacovigilance (QPPV)

  • Duties and responsibilities
  • Qualifications
  • QPPV vs national responsible person
  • Pecularities in MENA

 Dr Tanja Peters

Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim

Head PV Intelligence & Deputy EU-QPPV

10) Pharmacovigilance in the Middle East - Direct transfer of EU PV legislation?


Dr Mohammed Saleem

Boehmert & Boehmert, Representation Office Middle East and North Africa, JORDAN
 
General Director of SIPS (Science Forum for Research & Consultancy). He has served as a senior consultant to many UN organisations and in projects of the World Bank, the UNDP and the WHO. Dr Saleem has served as head of the IPR Committee & also as a member of the technical review board on herbal medicine & natural products at the Jordan FDA, as well as head of the LES-AC 'Life Science Committee'.

11) PSURs and RMPs – Tips for international markets

  • Global planning of PSUR schedules: solutions and strategies
  • How to ensure alignment of local RMPs with global RMPs

 Sven Schirp

Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim
 
Head of Global Pharmacovigilance Writing

12) Interpreting and implementing new PV requirements

  • Regulatory background
  • What is PV intelligence about?
  • Sources and what is relevant?
  • Public commenting
  • Impact assessment
  • Coordinating implementation activities

Dr Tanja Peters

Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim

Head PV Intelligence & Deputy EU-QPPV
Awards and cooperation partners
 
 

CONTACT

Lina Mohammed

+962 6 5512561

Lina.mohammed@sipsmena.com