European HEALTHCARE for PHARMACOEPIDEMIOLOGY and RISK MINIMISATION Studies

4^th Annual 3-day Course

15^th - 17^th March 2016
The Royal Society of Medicine, London

An understanding of the health care system and how medicine is practiced is essential to the design and planning of successful pharmacoepidemiological (PE) and risk minimisation (RM) studies. The course focuses on acquiring this practical knowledge and applying it to PE and RM studies in different therapeutic areas.

Learn from national academic and regulatory experts: 

Prof. Nicholas Moore, Prof. Edeltraut Garbe, Prof. Carlo Giaquinto, Prof. Tom Macdonald, Dr. Nawab Qizilbash, Prof. Ulf Bergman, Dr. Vera Ehrenstein, Prof. Miriam Sturkenboom, Prof. Helen Dolk, Dr. Diego Macias, Dr. Annalisa Rubino, Andrew Maguire, Dr. Gema Requena, Dr. Lorenzo Dominguez

Half Day for each ´Big 5´ country and, collectively, ´Small 5´ countries:

Part I: Understanding Health Care for Observational Studies

Part II: Secondary Data Studies

Part III: Field Studies (including patient registries, retrospective chart reviews and surveys)

Part IV: Practical - Designing and planning a pharmacoepidemiological study

And

• EU multi-country pharmacoepidemiological database studies,
• EU Risk Minimisation studies,
• EU multi-country pregnancy registries

Responses from delegates asked if they would recommend the course to colleagues:

• “Would recommend to colleagues at epi and safety department. Yes, good overview of the various health systems in EU and understanding of limitations to perform observational studies in EU”, Head Safety Evaluation and Risk Management, GSK Vaccines

• “Excellent overview of EU systems/ opportunities for studies. Acquired knowledge seems applicable (i.e. not too theoretical). Networking, high level of expertise of faculty”, Director, Epidemiologist, GSK Vaccines

• “Absolutely…Good exchange with teachers and among trainees. Very positive. Enjoyed a lot” Epidemiologist, Sanofi-Aventis Research and Development

• “Yes. First time that all different health care systems may be reviewed for so many countries” Risk Manager Officer / RMC Center of Excellence, Sanofi –Aventis

• “Yes, good overview, and right level of detail on some of the databases”, Head of Global HEOR, Novartis

• “Yes, very useful background of systems, structure and data sources”, Associate Director, Global Epidemiology and Observational Research, Takeda

• “Very useful to have in only 3 days an overview of different case systems where you can easily compare and confront differences and similarities”, Epidemiology Research Manager, Lundbeck SAS

Register Now!

 3^rd Annual 3-day Course:

European HEALTHCARE for PHARMACOEPIDEMIOLOGY and RISK MINIMISATION Studies

25^th - 27^th March 2015
The Royal Society of Medicine, London

An understanding of the health care system and how medicine is practiced is essential to the design and planning of successful pharmacoepidemiological (PE) and risk minimisation (RM) studies.

The course focuses on acquiring this practical knowledge and applying it to PE and RM studies in different therapeutic areas.

Learn from national academic and regulatory experts: 

Prof. Nicholas Moore, Prof. Edeltraut Garbe, Prof. Carlo Giaquinto, Prof. Tom Macdonald, Dr. Nawab Qizilbash, Prof. Ulf Bergman, Dr. Vera Ehrenstein, Prof. Miriam Sturkenboom, Prof. Helen Dolk, Dr. Diego Macias (Spanish Medicines Agency), Dr. Sabine Straus (PRAC member)

Half Day for each ´Big 5´ country and, collectively, ´Small 5´ countries:

Part I: Understanding Health Care for Observational Studies

Part II: Secondary Data Studies

Part III: Field Studies (including patient registries, retrospective chart reviews and surveys)

Part IV: Practical - Designing and planning a pharmacoepidemiological study

And EU multi-country pharmacoepidemiological database studies, EU Risk Minimisation studies & EU multi-country pregnancy registries

Responses from delegates asked if they would recommend the course to colleagues:

• “Would recommend to colleagues at epi and safety department. Yes, good overview of the various health systems in EU and understanding of limitations to perform observational studies in EU”, Head Safety Evaluation and Risk Management, GSK Vaccines

• “Excellent overview of EU systems/ opportunities for studies. Acquired knowledge seems applicable (i.e. not too theoretical). Networking, high level of expertise of faculty”, Director, Epidemiologist, GSK Vaccines

• “Absolutely…Good exchange with teachers and among trainees. Very positive. Enjoyed a lot” Epidemiologist, Sanofi-Aventis Research and Development

• “Yes. First time that all different health care systems may be reviewed for so many countries” Risk Manager Officer / RMC Center of Excellence, Sanofi –Aventis

• “Yes, good overview, and right level of detail on some of the databases”, Head of Global HEOR, Novartis

• “Yes, very useful background of systems, structure and data sources”, Associate Director, Global Epidemiology and Observational Research, Takeda

• “Very useful to have in only 3 days an overview of different case systems where you can easily compare and confront differences and similarities”, Epidemiology Research Manager, Lundbeck SAS

Register Now!

RISK MINIMISATION: Implementation and Evaluation of EU studies

2^nd One-DAY PRACTICAL WORKSHOP

24th March 2015
The Royal Society of Medicine, London

An understanding of risk minimisation is now key to the successful introduction and maintenance of drugs on the market.

This master class focuses on acquiring and applying the practical regulatory, scientific and logistical aspects of additional risk minimisation measures and their evaluation in the EU.

I. Theoretical approach and working framework for risk minimisation

II. Regulatory background

III. Available tools and guidance at the EU level

IV. Practical approach to the selection and development of additional risk minimisation measures — pre and post approval

V. Practical approach to the evaluation of the effectiveness of additional risk minimisation measures

VI. Review of the results of additional risk minimisation measures

VII. Challenges & ways forward: How regulators may react to various additional risk minimisation measures and studies—hypothetical scenarios

Speakers

• Dr. Sabine Straus, Medicines Evaluation Board the Netherands. Dutch PRAC member. Member of the writing committee for GVP module XVI on risk minimisation

• Prof. Jeffrey Aronson, Reader in Clinical Pharmacology, Oxford University and Honorary Consultant Physician, John Radcliffe Hospital. Member of Technology Appraisal Committee of NICE; Former Chief Editor of the British Journal of Clinical Pharmacology

• Dr. Nawab Qizilbash, Epidemiologist and Geriatrician, OXON and London School of Hygiene and Tropical Medicine, London

Responses from delegates asked if they would recommend the course to colleagues:

“An excellent opportunity to candidly share practical experiences with the new GVP guidance on risk minimisation and PASS studies in a small group environment with relevant stakeholders” Director, Medical Surveillance and Coding, Gilead

"Experts from academia and health authorities presenting and attending colleagues from other firms in a small group facilitated open discussion, true expert input and helped significantly in the understanding of the legislation/guidelines as well as the implementation challenges at industry side.” “This workshop was a "win-win-win" for the experts from academia, the regulators and the industry attendees." Associate Head Mature Products, Safety Science, Roche

Hear OXON (a preferred provider of EU PASS/risk minimisation studies to several big pharma) the Annual conference in Pharmacovigilance in Berlin in February

Join to discuss the latest regulatory frameworks for pharmacovigilance in Europe!
 

Key Practical Learning Points of the Summit:

• An update on the implementation of the new pharmacovigilance legislation with a particular emphasis on the regulatory aspects. 

• New features of the pharmacovigilance legislation and their impact on regulatory activities 

• New pharmacovigilance legislation and how it is impacting drug development 

• Drug Safety Management across a product`s lifecycle 

• Risk managemant and Monitoring Effectiveness of Risk Minimalisation 

• Latest Innovation and Trends in Drug Safety 

• Big data &Pharmacovigilance 

• Panel discussion on impact on drug development and approval

Read more

About the Masterclass:

The EMA expects MAHs to submit the new PSUR (PBRER) which marks a paradigm shift. The PSUR will change from being largely a document based online listings, narratives and simple sales-based incidence statistics to a benefit-risk tool with a much more statistical and quantitative approach to adverse event data, and including the incorporation of efficacy data. Risk minimisation measures have negative as well as positive consequences and these should be evaluated. The masterclass will provide attendees with the necessary exposure to approach the elements of benefit-risk analysis for the new PSUR in their company for new and old drugs and approaches to evaluate the positive and negative effects of risk minimisation measures.

Andrew Maguire BSc MSc FSS, Director of Global Epidemiology & Database Services at OXON Epidemiology’s Centre for Real World
Secondary Data, London. Andy is a statistical epidemiologist who has specialised in databases and quantitative benefit-risk analysis. He worked in the epidemiology departments of Pharmacia and Pfizer and subsequently at GPRD and THIN in the UK. Andy’s last post was as Director of Epidemiology and Database Analytics for Europe for a US multinational scientific service provider. In this role he led a group of epidemiologists and programmers undertaking real world pharmacoepidemiological research using medical databases, epidemiological modelling as well as epidemiological and burden of disease support for the pharmaceutical sector. He has developed a benefit-risk model with ex-European regulators. He has published in Lancet, among many other journals. He has recently authored a book chapter on quantitative benefit risk analysis and has used BRA models in regulatory submissions (FDA and EMA).

Ignacio Mendez VMD MPH, Director of HEAOR & Field Analytics at OXON Epidemiology’s Centre for Real World Field Studies, Madrid. Ignacio has more than 17 years of experience in epidemiology, health economics, patient-reported outcomes and associated statistical methodologies. He specialises in the application and analysis of PROs and health economic measures in observational and PASS studies. He is currently a member of the ENCePP HTA task force of the EMA.

Nawab Qizilbash MBChB MRCP(UK) BSc MSc DPhil(Oxon.) Clinical Epidemiologist & Head at OXON Epidemiology and; Honorary Senior Lecturer in Pharmacoepidemiology, London School of Hygiene & Tropical Medicine; Honorary Consultant Geriatrician, Madrid; Member of Green-Templeton College, Oxford University and ENCePP-nominated ‘EMA Expert’. Co-author of x5 Lancet, x1 JAMA and x3 BMJ publications in epidemiology, trials and meta-analysis. Chief editor of the internationally authored textbook: ́Evidence-based Dementia Practice ́ published by Blackwells, Oxford. Nawab was formerly: Director of Epidemiology & EBM at GlaxoSmithKline (1997-2005); Honorary Consultant Physician, Radcliffe Infirmary, Oxford; and chief editor of the Cochrane Dementia Group.

Read more

Overview

Learn about risk minimization studies, their implementation and evaluation in Europe from
two EMA experts: a regulator on the EMA PRAC committee and a clinical
pharmacoepidemiologist at ENCePP.

Why should you attend this masterclass:

• Discuss your challenges in risk minimisation
• Evaluate effectiveness of planned and ongoing risk minimisation
• Learn from real-life case studies and exercises
• Analyse the principles of risk management
• Increase effective alignment of risk studies and regulators
• Gain insights into the benefits of using an evidence-based toolkit

Dr Nawab Qizilbash MBChB MRCP(UK) BSc MSc DPhil(Oxon.) Head at OXON Epidemiology and; Honorary Senior Lecturer in Pharmacoepidemiology, London School of Hygiene & Tropical Medicine; Honorary Consultant Geriatrician, Madrid, Member of Green-Templeton College, Oxford University and nominated ‘EMA Expert’. Co-author of x5 Lancet, x1 JAMA and x3 BMJ publications in epidemiology, trials and meta-analysis. Chief editor of: ´Evidence-based Dementia Practice´. Nawab was formerly: Director of Epidemiology at GSK (1997-2005); Honorary Consultant Physician, Radcliffe Infirmary, Oxford; and chief editor of the Cochrane Dementia Group.

Dr Sabine Straus, Member of the PharmacoVigilance Risk Assessment Committee (PRAC) of the EMA since 2012 and Staff
Member of the Medicines Evaluation Board, Utrecht. Sabine was formerly Head of Pharmacovigilance at the Medicines Evaluation Board, Utrecht; Associate Professsor, Erasmus Medical Centre, Rotterdam; Senior Assessor Pharmacovigilance Medicines Evaluation Board. Memberships include: European Medicines Agency (EMA) working parties: Member Incident Review Network (IRN) and
European Risk Management Facilitation Group (ERMS).

Brochure         Programme         Registration Form

The course focuses on acquiring and using the knowledge of mechanisms, clinical features, diagnosis and the clinical investigation and management of major ADRs to correctly identify, classify, investigate, assess causality, conduct appropriate studies to establish causality and act accordingly. (This is NOT a course about case processing or regulations).

Practicals will be guided by a distinguished European multi-disciplinary faculty experienced in ADRs: 

• Clinical pharmacologist – Professor Jeffrey Aronson
• ICH/CIOMS expert – Professor Ralph Edwards
• Clinical epidemiologist – Dr Nawab Qizilbash
• Specialist clinician in the organ system of the ADR
• Industry PV expert—Marta Mariño

The masterclass will be led by Sabine Strauss, Member of the PharmacoVigilance Risk Assessment Committee (PRAC) of the EMA and formerly Head of Pharmacovigilance at the Dutch Medicines Evaluation Board and Nawab Qizilbash, Head of OXON; Honorary Consultant Geriatrician, Madrid; Honorary Senior Lecturer in Epidemiology, London School of Hygiene and Tropical Medicine; and an ‘EMA Expert’. 

Further information and registration

Brochure                     Programme                     Registration Form

An understanding of the health care system and how medicine is practiced is essential to the design and planning of successful pharmacoepidemiological and risk minimisation studies, including patient registries. The course focuses on acquiring this practical knowledge and applying it to pharmacoepidemiological and risk minimisation studies in many therapeutic areas, with interactive workshop sessions.

Learn from national academic experts: 

Prof. Eric Van Ganse, Prof. Edeltraut Garbe, Prof. Carlo Giaquinto, Prof. Adriana Ceci, Prof. Tom Macdonald, Dr. Nawab Qizilbash, Prof. Ulf Bergman, Dr. Vera Ehrenstein, Prof. Miriam Sturkenboom, Dr. Sabine Straus (PRAC member)

Half Day for each ´Big 5´ country and, collectively, ´Small 5´ countries:

Part I: Understanding Health Care for Observational Studies

Part II: Secondary Data Studies

Part III: Field Studies (including patient registries)

Part IV: Practical - Designing and planning a pharmacoepidemiological study

Responses from delegates asked if they would recommend the course to colleagues:

• “Absolutely…Good exchange with teachers and among trainees. Very positive. Enjoyed a lot” Epidemiologist, Sanofi-Aventis Research and Development

• “Yes. First time that all different health care systems may be reviewed for so many countries” Risk Manager Officer / RMC Center of Excellence, Sanofi –Aventis

• “Yes, good overview, and right level of detail on some of the databases”, Head of Global HEOR, Novartis

• “Yes, very useful background of systems, structure and data sources”, Associate Director, Global Epidemiologist and Observational Research, Takeda

• “Very useful to have in only 3 days an overview of different case systems where you can easily compare and confront differences and similarities”, Epidemiology Research Manager, Lundbeck SAS

• “Would recommend to colleagues at epi and safety department. Yes, good overview of the various health systems in EU and understanding of limitations to perform observational studies in EU”, Head Safety Evaluation and Risk Management, GSK Vaccines