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Learn about risk minimisation of drugs in Europe, its implementation and evaluation. The interactive masterclass will be led by the Joint Coordinator of the ENCePP Special Interest Group on Impact of PV Activities, who brings the experience of having conducted several risk minimisation projects.

 

Learn about expectations of EU regulators, how to identify, develop, implement and evaluate risk minimisation measures. This topic is relevant to drugs in phase III, drugs at the approval stage and newly approved and generic drugs with new safety issues requiring additional risk minimisation measures.

Learn from practical experience:

  • How to decide whether additional risk minimisation measures are needed
  • How to develop additional risk minimisation measures
  • How to evaluate risk minimisation measures
  • How to present evaluation results to regulators

Senior Vice Presidents, Vice Presidents, Directors, Heads of Department with responsibility in the following departments:

  • Pharmacovigilance 
  • Qualified Person of Pharmacovigilance (QPPV)
  • Clinical Directors 
  • Outsourcing Risk Management 
  • Quality Assurance
  • Signal Detection 
  • Adverse Drug Reactions
  • Safety
  • Epidemiology
  • Statistics
  • Medical Affairs
  • Project Management

Masterclass LEADER

keynote-img

Nawab Qizilbash

Head of OXON, OXON Epidemiology

Nawab Qizilbash - MBChB MRCP(UK) BSc MSc DPhil (Oxon.)
Head of OXON and:

• Honorary Senior Lecturer in Epidemiology, London School of Hygiene and Tropical Medicine, London University
• Honorary Consultant Geriatrician, Madrid
• Member of Green Templeton College, Oxford University
• Co-author of x6 Lancet, x1 JAMA and x3 BMJ publications in epidemiology, pragmatic trials and meta-analysis
• Chief editor of 'Evidence-based Dementia Practice' published by Blackwells, Oxford.

Joint Coordinator of the ENCePP Special Interest Group on Impact of PV Activities

Nawab was Director of Epidemiology and Evidence-based Medicine, GSK (1997-2005); he trained under and worked with Professor Sir Richard Peto F.R.S., and was founding editor of the Cochrane Dementia Group. He also trained in general internal medicine and geriatrics under Professor Sir John Grimley Evans and was Honorary Consultant Physician at the Radcliffe Infirmary, Oxford (1997-2000), and St's Mary's Hospital, London (2005-2006).

Among CROs in Europe, Nawab provides clients with a unique combination of high quality epidemiological and clinical experience covering many therapeutic areas

OXON Epidemiology

OXON Epidemiology is a European-based specialised full service scientific and operational provider for European and global safety and outcomes observational studies. OXON has been selected as a preferred provider by multiple companies for supporting global observational research.

OXON has a senior team with expertise in the areas of Epidemiology, Biostatistics, Safety, Health Economics, Patient-Reported Outcomes, Qualitative research and Operational implementation to support global observational studies; Our team have experience from industry (ex-big pharma employees), large CROs, academia and clinical medicine.

We have two European offices, based in London and Madrid, with an outpost in the USA to support US clients. The company was established in 2008, has grown steadily each year to best meet our client’s needs.

OXON's goal is to provide high quality, unbiased, evidence in the areas of drug safety, pharmacoepidemiology and health economics to the pharmaceutical industry, being our ethos to provide space and encouragement for original scientific thought so that projects benefit from the best design and execution.

Further information is available at www.oxonepi.com

 

Masterclass programme

8:30 Registration & Coffee

9:00 Opening remarks and introductions

Nawab Qizilbash

Nawab Qizilbash, Head of OXON, OXON Epidemiology
View Bio

9:10 Background and EMA regulations: Expectations of regulators

Nawab Qizilbash

Nawab Qizilbash, Head of OXON, OXON Epidemiology
View Bio

9:50 Decide if risk minimisation measures are needed

Nawab Qizilbash

Nawab Qizilbash, Head of OXON, OXON Epidemiology
View Bio

10:30 Morning Coffee

11:00 Selection and development of risk minimisation measures

Nawab Qizilbash

Nawab Qizilbash, Head of OXON, OXON Epidemiology
View Bio

11:40 Designs and sources for studies to evaluate risk minimisation measures

Nawab Qizilbash

Nawab Qizilbash, Head of OXON, OXON Epidemiology
View Bio

12:30 Lunch

12:50 Review of ENCePP studies

Nawab Qizilbash

Nawab Qizilbash, Head of OXON, OXON Epidemiology
View Bio

14:00 Opening remarks and introductions

Nawab Qizilbash

Nawab Qizilbash, Head of OXON, OXON Epidemiology
View Bio

14:10 Examples of evaluation studies

Nawab Qizilbash

Nawab Qizilbash, Head of OXON, OXON Epidemiology
View Bio

15:30 Afternoon Tea

16:00 Guidance for evaluation studies

Nawab Qizilbash

Nawab Qizilbash, Head of OXON, OXON Epidemiology
View Bio

16:40 Challenges and how to ensure respond to regulatory demands

Nawab Qizilbash

Nawab Qizilbash, Head of OXON, OXON Epidemiology
View Bio

17:20 Closing remarks

Nawab Qizilbash

Nawab Qizilbash, Head of OXON, OXON Epidemiology
View Bio

17:30 Close of Masterclass

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WHAT IS CPD?

CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

CPD AND PROFESSIONAL INSTITUTES

There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

As a formal provider of CPD certified activities, SMI Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

GLOBAL CPD

Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

CPD Certificates

We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@smi-online.co.uk

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