Pharmacovigilance Planning and Risk Management2020-06-19T12:36:14+00:00

Project Description

Pharmacovigilance Planning and Risk Management

Course overview

Venue: Online training

Date: 23 Sep – 24 Sep 2020

Risk management is a systematic approach to identifying, assessing, understanding, acting on, and communicating risk issues. All drugs have risks associated with their use, including adverse reactions, interactions between drugs, and the risk that the product may not work as effectively as expected. Manufacturers, regulators, health professionals, and patients all perform risk management activities.

A proactive approach to risk management of drug safety is vital throughout the whole life-cycle of a medicinal product. Our Pharmacovigilance Planning and Risk Management course will critically explore existing and developing strategies to plan and optimise risk management activities for known and potential risks of a newly approved product.

Understanding the drivers and relationships between safety specification, pharmacovigilance plans, risk minimisation programmes and pharmacoepidemiology will be a central theme. A panel of industry experts will share their personal experiences in managing the risk of bringing new medicines to market. They will outline new approaches to mitigating risk and improving decision making.

Group interactive sessions will analyse ‘real-world’ challenges faced by marketing authorisation holders and regulators.

Our interactive Pharmacovigilance Planning and Risk Management is designed for experienced staff, working in the  pharmaceutical industry (for regulatory authorities or research organisations), to critically explore existing and developing strategies to optimise risk management activities for known and potential risks of a product in its developmental stages, pre-authorisation, and for extending safety knowledge post-authorisation.

*Please note that the course dates and programme may be subject to change.

 Our courses are recognised by PharmaTrain.

Who should attend?

This course is aimed at:

  •  Pharmaceutical industry personnel from areas including pharmacovigilance, clinical research, medical affairs, medical writing, regulatory affairs and medical information
  • Staff from regulatory authorities

How our courses work

  • Taught over two days
  • Small class size allows for one-to-one interaction with expert tutors
  • A combination of short lectures, practical workshops and interactive discussion sessions
  • Taught by a panel of expert speakers (minimum of four speakers per course) from industry, regulatory authorities and academia
  • Course materials including presentations, workshop material and suggested reading documents are made available electronically during the course
  • The agenda provides ample opportunity to network with expert speakers and your fellow delegates

Lunch, refreshments and all course materials are included in the registration fee.

Aims of course

  • To critically appraise the elements of a Risk Management System through evaluation of the relationships between pharmacovigilance and risk management plans
  • To prepare for construction of Safety Specification and Risk Management Plans through critical evaluation of the latest concepts in tools and strategies for risk assessment and prevention
  • To critically examine current recommendations and practices of managing risk and analyse the implication for decision making

Learning Outcomes

On successful completion of this course delegates should be able to:

  • Critically interpret the purposes of Risk Management Systems in drug safety and the challenges that Risk Management represents
  • Plan, prepare and justify Safety Specification and Risk Management Plans
  • Demonstrate a critical awareness of models for safety agreements and have basic knowledge and skills required to proactively manage the development and execution of a safety agreement with a partner

Key Topics

Programmed features:

  • Current regulation and guidance relevant to global risk management
  • Safety specification and pharmacovigilance planning
  • Risk management activities and the drug development programme
  • Stakeholder perspectives on construction and execution of Risk Management Plans
  • Development of best practice techniques
  • Management of drug safety after reclassification


Registration fee includes 20% discount as this course is now being taught online.

Cost Per Delegate:

£620 + VAT Academic

(Academic Units, Public Sector Organisations, Registered Charities)


£952 + VAT Standard

(Standard Registration)

Download Course Programme

Click here to download the programme


Booking options

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“Speakers were great with extensive knowledge on the Risk Management. It was great to see industry view vs MHRA.”

Risk Management Delegate 2019

“Various aspects of risk management covered very comprehensively. Excellent course and very worthwhile. Helped validate my understanding of EU RMP requirements.”

Risk Management Delegate 2019

“Very well organised, a great venue and good variety of speakers. An enjoyable and informative course.”

Risk Management Delegate 2019

“Really interesting and experienced speakers. All questions very well answered.”

Risk Management Delegate 2018

“Very informative and comprehensive course with good interactive sessions. Good, qualified speakers covered relevant topics in detailed manner.”

Risk Management Delegate 2018

Dr Lesley Wise – Managing Director

Dr. Lesley Wise is an established pharmacovigilance professional with more than 15 years of experience in pharmacovigilance both in medicines regulation as head of the risk management and pharmacoepidemiology group at the MHRA, and in the pharmaceutical industry as vice-president and global head of Risk Management Centre of Excellence and Pharmacoepidemiology at Takeda. This included leadership of the pharmacoepidemiology team, signal processes, risk management processes, and benefit-risk assessments as well as external facing research initiatives and working on the recent ICH update to section 2.5.6 of the CTD (Benefit-Risk).

After leaving nursing 25 years ago Lesley obtained a BSc in Mathematics with Statistics, an MSc in Medical Statistics, and a PhD in Genetic Epidemiology (Methods for meta-analysis of genome-wide linkage data). She is also an honorary lecturer at the London School of Hygiene and Tropical Medicine and an associate editor of Therapeutic Advances in Drug Safety.

Contact Info

Drug Safety Research Unit Bursledon Hall, Blundell Lane, Southampton, SO31 1AA, U.K.

Phone: +44 (0)23 80 40 86 00

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