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The SMi Group are pleased to announce their 5th Drug Safety Conference, taking place on the 11th – 12th June 2018 in Central London.

For any drug, anywhere, its safety in patients is a huge issue that is constantly under surveillance, irrespective of where the drug is in its pipeline.

The Global Pharmaceutical Market currently has a market value of $1057 billion. If a drug is found to be unsafe, causing serious side effects, it can have a huge knock on effect on revenue, causing huge losses to pharmaceutical companies manufacturing the drug.

Therefore, Drug Safety 2018 aims to discuss the latest findings and current thinking on pharmacovigilance. Importantly, it will address the newest regulatory updates and interpretations of them, including the impact of the vital and much awaited Clinical Trial Regulations. For more information, please see the benefits of attending or download our brochure! 

 

 

 


 

  • Benchmark against other industry leaders in strategies to maintain a global pharmacovigilance system that serves all requirements
  • Learn how to remain compliant with the latest regulatory updates
  • Hear an MHRA spotlight presentation on the future of Clinical Trial Regulations
  • Evaluate the EMA's new Eudravigilance system and discuss first experiences
  • Know the current methods of improving signal detection
  • Understand how best to manage and report adverse effects
  • Discuss how to manage safety data and communicate it with patients and other stakeholders

This event is suitable for all professionals involved in Drug Safety and Pharmacovigilance. Suggested job titles include: 

Vice Presidents, Directors, Heads, Managers, QPPVs of:

  • Drug safety
  • Pharmacovigilance
  • Regulatory Affairs
  • Risk Management and Surveillance
  • Clinical Safety
  • Patient Safety
  • QPPV (Qualified Person for Pharmacovigilance)
  • EU QPPV (European Qualified Person for Pharmacovigilance)
  • CMO

PAST ATTENDEES INCLUDE:

Abbott
ABPI
ACRAF
Actelion Pharmaceuticals
Allergan
Alliance Pharmaceuticals
Alliance Unichem Plc
Amgen
ArisGlobal
Arrow No. 7 Limited
Astellas
Aston University
Astra Zeneca
Audit PV Limited
Austrian Agency for Health and Food Safety
Aventis Pharmaceuticals
B O R A
BAH- Bundesfachverband Der Arzneimittel-Hersteller EV
Bayer
Biogen Idec
Biostat Cercles
Bluefish pharmaceuticals
Boehringer Ingelheim
Bristol-Myers Squibb
Bristows LLC
BTG
Cancer Research UK
CB Consulting
Celgene S.L.
Cephalon Inc
Crossoak Pharma
CRUK
Daiichi Sankyo
Danish Medicines Agency
Dexcel Pharma Ltd
Dexcel-Pharma Limited
Diamond PV Services
Dong-A ST Co., Ltd.
Dr Reddys
Drug Safety Research Unit
DSM Nutritional Products AG
Eisai
Elan
Eli Lilly & Company Ltd.
EudraVigilance Consultants
European Medicines Agency (EMA)
European Public Health Alliance
F. Hoffmann-La Roche
FDA
Federal Agency for Medicines and Health Products
Gedeon Richter Plc, Medical
Genzyme
Gilead Sciences
GlaxoSmithKline
Global Safety Vigilance
Grunenthal Gmbh
H. Lundbeck A/S
Harefield Pharmacovigilance
Human Drug Information
Infarmed
Institute of Cancer Research
International Federation Of Pharmaceutical Manufacturers Associations (I F P M A)
Janssen
Johnson & Johnson
Karyopharm Therapeutics Inc
Kyowa Hakko Kirin UK Ltd
Labatec Pharma S.A.
Leuphana Universität Lüneburg
Lilly Research Centre Ltd
London School of Hygiene & Tropical Medicine
MAJU Islamabad
MAPI-EPI
Martindale Pharmaceuticals
Med Immune
Medac GmbH
MedDRA Maintenance and Support Services Organisation (MSSO)
Medicines & Healthcare Products Regulatory Agency (MHRA)
MedImmune
Merck & Co.
MorphoSys AG
Mundipharma
Mylan
National Patient Safety Agency
NDA Group
Neuro Search A / S
Norgine Ltd
Novartis
Novo Nordisk
Nycomed Group
Orion Clincial Services
Ortho-McNeil Janssen Scientific Affairs
OXON Epidemiology
Panacea Pharma Projects Limited
PAREXEL International
Paul Ehrlich Institut
Pfizer
PharmaTracks
ProductLife Ltd
Professional Information Ltd
Prostrakan Group Plc
QED Clinical Services
Quantum Solutions India
Quintiles
Quintiles (UK) Ltd
Reckitt Benckiser Pharmaceuticals Inc
Recordati Spa
Red Door Communications
Renova Pharma Safety
Roche
Royal College of Physicians London
Sandoz International Gmbh
Sanofi Aventis
Sanovel
Schering-Plough
Servier Do Brasil Ltda
Shionogi & Co., Ltd.
Sidley Austin Brown & Wood
Solvay Gmbh
Solvay Pharmaceuticals
Stallergenes
Swissmedic
Tabriz Consulting Ltd
Takeda UK Ltd
Teva Industries Ltd
TEVA Ltd
TEVA Pharmaceuticals
Therabel Pharma
TranScrip Partners
UCB Pharma
University Hospitals Of Geneva
University of Glasgow
University of Hertfordshire
University Of Liverpool
University of Surrey
University of Valladolid
University Of Warwick
Uppsala (Sundbro) Airport
Vifor Pharma
Vigireg
W C I Consulting
Wainwright Associates Limited
WCI Group
WHO Collaborating Centre for International Drug Monitoring
World Health Organization
Wyeth Research
Zayed Military Hospital
 

Conference programme

8:30 Registration & Coffee

9:00 Chair's Opening Remarks

Susan Welsh

Susan Welsh, Chief Safety Officer, CSL Behring
View Bio

9:10 KEYNOTE PRESENTATION: Risk management of medicines in pregnancy - from thalidomide to valproate

David Lewis

David Lewis, Senior Adviser Pharmacovigilance, CMO Patient Safety, Novartis
View Bio

• There has been a lack of systematic research to understand the adverse effects of exposure to medicinal products during pregnancy in humans
• This constitutes a growing safety concern, illustrated by the first public hearing held by the EMA (on valproate-containing medicines)
• The challenge spans the lifecycle of medicines from discovery to general sales
• New tools and techniques need to be developed and brought in to operation to improve risk minimization and protect public health

9:50 SPOTLIGHT PRESENTATION: The future of clinical trial regulations

Kirsty Wydenbach

Kirsty Wydenbach, Deputy Unit Manager, Clinical Trials Unit, MHRA
View Bio

• Overview of the major changes that will be implemented in 2019
• Harmonising the assessment and supervision processes for clinical trials throughout the EU, via an EU portal and database
• Learn how the new regulations will increase the efficiency of all trials in Europe whilst avoiding unnecessary duplication
• Understand what this means for drugs currently in clinical trial pipelines
• Guidelines for applying the regulatory changes to current clinical trials
• A timeline of when these changes will have to be made by

10:30 Morning Coffee

11:00 50 Shades of Grey - Tackling difficulties in interpreting pharmacovigilance regulations

Sue Rees

Sue Rees, Executive Director, Global Safety, Amgen
View Bio

• Challenges faced in interpreting legislation and guidance
• Engaging with stakeholders to influence change in legislation and guidance
• Pragmatic compliance – practical ways to approach uncertainty

11:40 Local PV requirements from a HQ perspective

Kashif Sheikh

Kashif Sheikh, Senior Safety Surveillance Advisor , Novonordisk

· Challenges in the rising number of signal management and signal reporting requirements around the world
· HQ experience in accommodating all requirements
· Ensuring compliance in a pragmatic way

12:20 PANEL DISCUSSION: The impact of Brexit on regulations: Maintaining a global pharmacovigilance system that serves all requirements

• How is Brexit affecting the drug safety regulations worldwide?
• EMA regulations after Brexit in the UK and in Europe
• How should companies remain compliant with everyone?
• What are future challenges for drugs safety?
• How should these challenges be tackled?

Kirsty Wydenbach

Kirsty Wydenbach, Deputy Unit Manager, Clinical Trials Unit, MHRA
View Bio

Sue Rees

Sue Rees, Executive Director, Global Safety, Amgen
View Bio

Jackie Roberts

Jackie Roberts, Director of Regulatory, Pharmacovigilance and Medical, Actavis
View Bio

David Lewis

David Lewis, Senior Adviser Pharmacovigilance, CMO Patient Safety, Novartis
View Bio

13:00 Networking Lunch

14:00 Pharmacovigilance (PV) In Gulf and Arab Countries: a prospective review!

Rawya Al Kredly

Rawya Al Kredly, Head of Medical Affairs Department, Julphar
View Bio

• Present PV standard scenarios in Gulf and Arab Countries.
• Various country-specific PV guidelines in the region.
• Common Arab PV guideline.
• Challenges faced for PV expansion.
• Way forward and future scope of PV Development in the region.

14:40 Pharmacovigilance stakeholder management – how we manage the interactions the PV department has internally and externally

Jackie Roberts

Jackie Roberts, Director of Regulatory, Pharmacovigilance and Medical, Actavis
View Bio

• Case study – PV stakeholders in a generic company
• Managing change, maintaining compliance
• Impact of events – eg Brexit

15:20 Afternoon Tea

15:50 Pharmacovigilance outsourcing: The evolving model

Simon Ashworth

Simon Ashworth, VP, EU Qualified Person for Pharmacovigilance (QPPV) and Head EU Compliance and Marketed Products, Takeda Pharmaceuticals

• How the model of PV outsourcing is changing
• How we can make outsourcing more strategic
• Ensuring adequate vendor oversight and cost effectiveness

 

17:10 Effective communication & Patient centric Pharmacovigilance

John Solomon

John Solomon, Head of Pharmacovigilance-UK & Ireland, Sanofi

• Role of communication in risk minimisation
• Role of communication in health literacy

17:50 Chair’s Closing Remarks and Close of Day One

Susan Welsh

Susan Welsh, Chief Safety Officer, CSL Behring
View Bio

8:30 Registration & Coffee

9:00 Chair's Opening Remarks

Susan Welsh

Susan Welsh, Chief Safety Officer, CSL Behring
View Bio

9:10 KEYNOTE PRESENTATION: Benefit-Risk Evaluations: The patient perspective

Peter De Veene

Peter De Veene , Senior Vice President, Head Global Drug Safety and Q.P.P.V., Grünenthal

• Integrating patients into the drug safety process: The earlier the better
• Adapting clinical trials to include patients into the development process
• Developing a two-way conversation
• Analysing what risks are acceptable, and how this changes as the disease progresses

9:50 KEYNOTE PRESENTATION: Risk management and risk minimisation: where are we now?

Saad Shakir

Saad Shakir, Director, Drug Safety Research Unit
View Bio

• Relevant updates of Module V on risk management
• Practical examples for handling risk management and risk minimisation commitments
• Approaches for studies that address the regulatory needs

10:30 Morning Coffee

11:00 Risk Management Planning – Practical considerations when Implementation of GVP V - Rev 2

Bjarke Naver

Bjarke Naver, Head of Pharmacovigilance Science, LEO Pharma A/S

• Key changes in the GVP Module V - Rev 2
• Implementing the new guidance in practice
• Working with the new template
• Core RMP’s and Local RMP’s – for and against

 

11:40 Evaluation of Risk Minimisation in Europe

Nawab Qizilbash

Nawab Qizilbash, Head of OXON, OXON Epidemiology
View Bio

• Quantitative Review of Studies at EMA
• Case studies
• Lessons for regulators and pharma

12:20 Networking Lunch

13:20 Safety considerations in Patient Support Programmes (PSPs), Market Research, and other Externally Facing Activities

Philip Eichorn

Philip Eichorn, Senior Director, Worldwide Safety and Regulatory, Pfizer Group
View Bio

• What should safety/PV departments need to know about PSPs, Market Research, and other non-study outward-facing activities? What are the regulatory expectations?
• How to effectively partner with other parts of the business to mitigate unexpected safety-related issues.
• How programme design can influence a product’s apparent Benefit-Risk balance
• How to promote quality of safety-related information from these programmes

14:00 Safety Assessment Committees: Anatomy, Physiology and Pathology

Amer Alghabban

Amer Alghabban, GXP Compliance and Training Partners, GXP Compliance and Training Partners
View Bio

• DSMB, DMC, SMB, DSMC, IDMC, and SAC: what is in the name
• How do authorities do the safety assessment
• Roles and responsibilities of safety committees
• Challenges of safety committees
• Lessons learnt

14:40 Afternoon Tea

15:10 Signal Detection and Management 2018 in the EU: First experiences with Eudravigilance

Bert Van Leeuwen

Bert Van Leeuwen, Deputy QPPV , Astellas
View Bio

• Informing the EMA and national competent authorities of validated signals
• A review of our experiences so far
• Developing and finalising a process for Eudravigilance

(Bullet points to be confirmed by the speaker.) 

15:50 ICSR Download from Eudravigilance in practice: First experiences and hurdles with generic products

Heike Benecke

Heike Benecke, Director, Vigilance at Mundi Pharma, Solvay Pharmaceuticals

  • Hurdles in the management of E2BR3 cases in E2BR2 environment
  • First experiences using Eudravigilance download functionalities
  • Management of Eudravigilance cases in global environment
  • Effect of Eudravigilance cases in safety data base on MAH signalling activities and processes: effects of “conservative” case download
  • 16:30 Is more always better? Non-value added reports from patient support programmes as an example of the ‘precautionary reporting bias’

    Kevin Klein

    Kevin Klein, Project Manager, Lygature
    View Bio

    • A large number of nonvalue-added reports have been accumulating in ADR databases that can potentially impede safety signal detection
    • The extensive patient contact by MAHs in such patient support programs was identified as an important source of such nonvalue-added reports
    • These reports could be regarded as precautionary reports by MAHs to meet regulatory requirement
    • In this presentation, we demonstrate the suppressing effect of such precautionary reports on statistical signal detection methods

    17:40 Chairman’s Closing Remarks and Close of Day Two

    +

    FEATURED SPEAKERS

    Amer Alghabban

    Amer Alghabban

    GXP Compliance and Training Partners, GXP Compliance and Training Partners
    Bert Van Leeuwen

    Bert Van Leeuwen

    Deputy QPPV , Astellas
    David Lewis

    David Lewis

    Senior Adviser Pharmacovigilance, CMO Patient Safety, Novartis
    Jackie Roberts

    Jackie Roberts

    Director of Regulatory, Pharmacovigilance and Medical, Actavis
    Kevin Klein

    Kevin Klein

    Project Manager, Lygature
    Kirsty Wydenbach

    Kirsty Wydenbach

    Deputy Unit Manager, Clinical Trials Unit, MHRA
    Nawab Qizilbash

    Nawab Qizilbash

    Head of OXON, OXON Epidemiology
    Peter De Veene

    Peter De Veene

    Senior Vice President, Head Global Drug Safety and Q.P.P.V., Grünenthal
    Philip Eichorn

    Philip Eichorn

    Senior Director, Worldwide Safety and Regulatory, Pfizer Group
    Rawya Al Kredly

    Rawya Al Kredly

    Head of Medical Affairs Department, Julphar
    Saad Shakir

    Saad Shakir

    Director, Drug Safety Research Unit
    Sue Rees

    Sue Rees

    Executive Director, Global Safety, Amgen
    Susan Welsh

    Susan Welsh

    Chief Safety Officer, CSL Behring

    Amer Alghabban

    GXP Compliance and Training Partners, GXP Compliance and Training Partners
    Amer Alghabban

    Amer is currently the Managing Director of GxP Compliance and Training Partners (GCTP) helping pharmaceutical companies to achieve compliance with GCP, GVP, GCLP and GLP.

    Amer has over 27 years experience in the pharmaceutical industry. He has been an invited speaker at over 110 international congresses.

    Mr. Alghabban has published 2 reference books, The Pharmaceutical Medicine Dictionary and The Dictionary of Pharmacovigilance and other publications.

    He was Assistant Editor for 11 medical journals and an invited Course Director for Pharmacovigilance Auditing at the UK RQA.

    As part of his current role as QA Expert, he is serving as Global Head of QA for Allecra Therapeutics SAS and has served as VP of GxP Quality Assurance, Compliance at Karyopharm Therapeutics Inc. and similarly as the Senior QA representatives of Biotech companies in Switzerland and the U.K.

    Prior to GCTP, he was Global Director, Head of Quality Assurance & Audit Management at Merck Serono, Geneva, Switzerland. His other previous positions included Global Head of GxP Quality Assurance at Arpida Ag., Switzerland, Senior International Clinical Quality Assurance Audit Manager at Novartis Headquarters, Basel, Switzerland and he was the first Pharmacovigilance Compliance Officer of the MHRA in the UK.
     

    Bert Van Leeuwen

    Deputy QPPV , Astellas
    Bert Van Leeuwen

    Bert van Leeuwen is the deputy-QPPV of Astellas Pharma. After obtaining his MD he worked in various hospitals for several years. Now working in Pharmacovigilance for over 15 years, he started at Organon leading two Therapeutic Areas, both for marketed products as well as clinical trials, in a quickly growing PV department; he was also closely involved with the implementation of Core Safety Data Sheets, MedDRA and the setup of a Signal Detection system. Thereafter he led the ‘Quality in PV’-group, implementing a Compliance Monitoring system and the PV Intelligence system as well as managing regulatory inspections. After the take-over by Schering-Plough he was actively involved in merging the two PV Quality Document systems. Then moving to Astellas, he led one of the two Therapeutic Groups in PV, before accepting his current role. Next to the daily work he attended many conferences globally since 2000, some as a speaker, most of the time about PV Legislation, Signal Detection and PV Outsourcing; his last publications (in Therapeutic Innovation & Regulatory Science 2017;51;1:11-15 and Pharmaceutical Medicine, 2017, Online First) were on the same subject. He is an active member of a group of PV professionals working on a standard for PV outsourcing.

    Bjarke Naver

    Head of Pharmacovigilance Science, LEO Pharma A/S
    Bjarke Naver

    David Lewis

    Senior Adviser Pharmacovigilance, CMO Patient Safety, Novartis
    David Lewis

    Dr Dave Lewis joined Novartis in March 2007 following 20 years’ pharmacovigilance at GSK and at Shire Pharmaceuticals. He was appointed EU QPPV at Novartis Pharma AG from April 2009 then moved to Global Head of Pharmacovigilance Systems and Data Management, followed by Global Head of Pharmacovigilance in February 2011. He was confirmed as Global Head of Pharmacovigilance (including vigilance for medical devices) for Novartis Patient Safety in June 2016 and moved to Senior Adviser in September 2017. Dr Lewis has worked in country affiliates and in a variety of global safety & risk management functions with both investigational & marketed products, as well as in roles concerned with systems and processes. Dr Lewis is the author of papers on the safety of medicines as well as research papers on neuropharmacology. He has a number of academic links, including being named Senior Visiting Research Fellow, Faculty of Pharmacy, Pharmacology & Postgraduate Medicine, University of Hertfordshire. Dr Lewis is Project Coordinator for the IMI WEB-RADR consortium (@ http://www.web-radr.eu), and Work Package Co-Leader for IMI Conception (@https://www.imi.europa.eu/sites/default/files/uploads/
    documents/apply-for-funding/call-documents/imi1/DraftTopic2017_PregnancyBreastfeeding.pdf)

    Jackie Roberts

    Director of Regulatory, Pharmacovigilance and Medical, Actavis
    Jackie Roberts

    Dr Jackie Roberts is the Executive Director of Regulatory, Pharmacovigilance and Medical working at Accord Healthcare Ltd one of the leading European generic companies.

    Jackie has a PhD in clinical pharmacology from Imperial College, London and an MBA from Warwick Business School. Her previous experiences cover the NHS, industry, consultancy and the UK Competent Authority.

    Over the last six years Jackie has experienced many changes as the company she works for was involved in many merger and acquisition activities, this has brought challenges as the roles, structures and strategies have all changed multiple times but the underlying requirements to maintain compliance and ensure patient safety has remained.
     

    John Solomon

    Head of Pharmacovigilance-UK & Ireland, Sanofi
    John Solomon

    Kashif Sheikh

    Senior Safety Surveillance Advisor , Novonordisk
    Kashif Sheikh

    Kevin Klein

    Project Manager, Lygature
    Kevin Klein

    Kevin Klein is a project manager at Escher, the Lygature platform for regulatory innovation, and PhD student at the WHO Collaborating Centre at Utrecht University. After finishing his Bio-Pharmaceutical Science degree at Leiden University in 2013, he started working for Exon Consultancy in the field of pharmaceutical policy and regulation. During his work as a consultant he was also involved in a number of Escher projects related to the topic pharmacovigilance and biologics. In 2015, Kevin Klein started his PhD in regulatory science studying the (lack of) alignment between regulators and practice, and how this impacts regulatory compliance.

    Kirsty Wydenbach

    Deputy Unit Manager, Clinical Trials Unit, MHRA
    Kirsty Wydenbach

    Kirsty joined the MHRA in 2009 as a Medical Assessor in the Clinical Trials Unit. She has been involved in the UK regulation of clinical trials across all therapy areas and all phases of development, including trials for both chemical and biological products, Advanced Therapy Products and many first-in-man studies. She has also been involved in European discussions aiming to establish an EU harmonised approach to decisions regarding clinical trials, particularly for Developmental Safety Update Reports (DSURs) and also including Voluntary Harmonised Procedure (VHP) applications. More recent EU priorities have included the new Clinical Trial Regulation and Kirsty currently sits on the safety subgroup of the Clinical Trials Facilitation Group (CTFG) that is working on how this will be implemented. She is also the co-chair for safety for the EU NTC Curriculum for European regulatory agency assessors and was an EMA expert for the update of the First-in-Human guideline.

    Lisa Benaise

    Global Head, Galderma International
    Lisa Benaise

    Nawab Qizilbash

    Head of OXON, OXON Epidemiology
    Nawab Qizilbash

    Nawab Qizilbash

    Head of OXON, OXON Epidemiology
    Nawab Qizilbash

    Nawab Qizilbash MRCP DPhil(Oxon). Clinical Epidemiologist at OXON Epidemiology; and
    • Honorary Associate Professor, London School of Hygiene and Tropical Medicine;
    • Honorary Consultant Geriatrician, Madrid.
    • Joint Coordinator of the EMA ENCePP Group to evaluate impact of PV Activities.

    Previously: Director of Clinical Epidemiology, GSK; Honorary Consultant Physician, Oxford.
    He leads studies with the eminent Professor of Medical Statistics, Stuart Pocock, London School of Hygiene and Tropical Medicine and Professor Jeffrey Aronson, ADR Expert, Oxford and designs and helps implement cost-efficient, multi-country primary and secondary data collection (and hybrid) PASS studies for industry.

    Peter De Veene

    Senior Vice President, Head Global Drug Safety and Q.P.P.V., Grünenthal
    Peter De Veene

    Philip Eichorn

    Senior Director, Worldwide Safety and Regulatory, Pfizer Group
    Philip Eichorn

    Dr Eichorn did his medical training in the US and practiced general adult medicine in the outpatient and hospital settings for 10 years before joining the pharmaceutical industry. He joined Pfizer (UK) in 2002 and since then has served a number of roles in the safety, risk management and regulatory documentation functions, including provision of cross-portfolio guidance on the RMP. Much of his current work also focuses on partnering with commercial and other non-safety colleagues to promote the quality of AE reports resulting from patient support programs, market research and other activities that involve communication between the company and HCPs, patients and consumers.

    Rawya Al Kredly

    Head of Medical Affairs Department, Julphar
    Rawya Al Kredly

    Rawya Kredly finished her Masters in Clinical Pharmacy with Distinction from Queen’s University, Belfast United Kingdom.

    Presently Rawya is the Director of Medical Affairs Department with additional role of Qualified Person for Pharmacovigilance for Gulf Pharmaceutical Industries (Julphar) UAE. She comes with rich experience of all medical affairs processes covering entire Middle East-North Africa (MENA) region in her long career of nearly twenty years in pharmaceutical industries. Prior to joining Julphar, she was working with Hikma Pharmaceuticals, Jordan.

    Rawya Kredly is very enthusiastic about Pharmacovigilance considering it is emerging subject in MENA region and willing to contribute within this development process.
     

    Saad Shakir

    Director, Drug Safety Research Unit
    Saad Shakir

    Saad Shakir has been working in pharmacovigilance & pharmacoepidemiology for more than a decade.

    He is Director of the Drug Safety Research Unit (DSRU) in Southampton. The DSRU is an academic Unit associated with the University of Portsmouth. Here he leads a research team with an active programme for monitoring and studying the safety of medicines.

    He has worked and advised on many drug safety issues including product withdrawals and major safety hazards. He is an author of many publications on pharmacovigilance and pharmacoepidemiology and is a member of the editorial board of the journals of Pharmacoepidemiology and Drug Safety.
     

    Simon Ashworth

    VP, EU Qualified Person for Pharmacovigilance (QPPV) and Head EU Compliance and Marketed Products, Takeda Pharmaceuticals
    Simon Ashworth

    Sue Rees

    Executive Director, Global Safety, Amgen
    Sue Rees

    Sue has been in the pharmaceutical industry for over 25 years. Sue joined Amgen in 2013 as EU QPPV, based in the Cambridge office. Sue works closely with the Global Patient Safety team and a network of local safety officers to provide oversight of patient safety across the EU.

    Sue sits on the Efpia Pharmacovigilance Expert Group and is an honorary Fellow of PIPA (Pharmaceutical Information and Pharmacovigilance Association).

    Prior to joining Amgen Sue spent 3 years at Eisai Europe Ltd as Head of International Pharmacovigilance and EU QPPV having previously held various roles in safety, medical information and marketing for GlaxoSmithKline and AstraZeneca operating at both the affiliate and global level. Sue holds a BSc (Hons) in Biochemistry and MSc in Immunology.
     

    Susan Welsh

    Chief Safety Officer, CSL Behring
    Susan Welsh

    CSL Behring is a global company which conducts business in 60 countries and is headquartered in Australia. The company has a remarkable and industry-leading patient-centric approach truly placing patients first and foremost. Currently the company is experiencing strong growth and is expanding. Susan heads the global PV function at this exciting and dynamic company. She has 28 years of industry experience with over 15 years overseeing PV directly or as part of clinical development/medical affairs roles. Before CSL, Susan served as Chief Safety Officer of Sanofi, VP of Safety Strategy at Pfizer, and VP Medical Safety at BMS.

    Earlier in her career, Susan held senior roles in medical affairs, clinical development, general management, finance and IT. She worked as Chief Knowledge Officer at Monsanto and then as Corporate Officer, SVP & Chief Science Officer at Express Scripts, establishing the company by designing formulary strategies e.g. multi-tier formulary and specialty distribution services and co-founding one of the world’s first real world evidence companies, Practice Patterns Science. Following this she served as CEO Charis Pharma and as CEO Snowdon Pharma successfully transferring the companies on when key milestones were achieved.

    Susan holds an MBChB (British equivalent MD) and Bachelor of Science from University of Leeds, UK. Her Master's Information Management is from Washington University, St. Louis, USA, and her MBA is from the University of California at Berkeley, USA. Susan is a licensed physician with UK practicing rights. She is an elected Fellow, Faculty of Pharmaceutical Medicine, Royal Colleges of Physicians UK (FFPM), Member, Royal College of General Practitioners, UK and Royal College of Psychiatrists UK, Diplomate, Royal College of Obstetricians & Gynaecologists UK, and Member, American College of Physicians.

    Before industry, Susan practiced medicine for 10 years in UK later serving for 6 years as a military officer in Britain's Royal Air Force being promoted to the rank of Squadron Leader and completing many military challenges around the world.

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    Drug Target Review’s quarterly magazine, website and annual events program provides high quality content with peer-written articles that are submitted exclusively by the world’s most respected scientists in their field. This attracts a committed base of readers, users and delegates made up of senior decision-makers from the life science and drug discovery industries at the top pharmaceutical companies, as well as academics and scientists from the top research institutes across the globe.


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    PharmaVision offers a consultancy service providing independent pharmaceutical thematic research to the healthcare industry, the investment community and competitive intelligence specialists. We perform due diligence research and provide expert commentary in healthcare. Our reports combine scientific analysis in drug delivery, R&D technologies and pharmaceutical products including patient modelling, product/technology forecasts and market trends evaluation.


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    Founded in 2000, Technology Networks is established as the leading news provider for life science and drug discovery professionals. In addition, we provide unique content including webcasts, videos, application notes and posters from recent conferences. Our portfolio now includes around 30 focussed scientific communities, all of which are accessible free of charge within TechnologyNetworks.com


    Journal for Clinical Studies – Your Resource for Multisite Studies & Emerging Markets

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    Published bi-monthly.JCS is a unique journal, dedicated to providing information to the global pharmaceutical, biotechnology, medical devices and contract research organisations. JCS details practical and theoretical operational procedures, challenges, validatory and regulatory guidelines when conducting trials on a multisite basis and particularly within the emerging markets, naïve patient population, and remote access areas. JCS provides country by country objectives and uniquely brings you experiences in therapeutic areas of Liver diseases, kidney diseases, insect borne diseases, malnutrition and under nutrition. JCS is led by a strong editorial advisory board sourced out for their experiences; you will get the most practical insight for your global studies. JCS invites you to join us, write for us, feature your experiences with us, advertise your capabilities with us, and ask our advisory board for suggestions and guidelines. Let us make health care available to all.


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    Pharmalicensing

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    Pharmalicensing (www.pharmalicensing.com) is the premier biopharmaceutical Open Innovation resource designed for professionals involved with partnering, licensing and business development worldwide. Actively supporting all forms of partnering and in- and out-licensing activities, Pharmalicensing utilizes the unique Partnering Search service and its global network of industry experts to enable companies to identify and engage with appropriate partners around the world. Pharmalicensing, and its sister service Medical Device Licensing (www.medicaldevicelicensingcom) are actively utilized by over 200,000 industry professionals each month. Pharmalicensing is a division of IP Technology Exchange, Inc.

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    Holiday Inn Kensington Forum

    97 Cromwell Road
    London SW7 4DN
    United Kingdom

    Holiday Inn Kensington Forum

    Holiday Inn Kensington Forum is perfectly situated in one of London’s most luxurious and beautiful areas within South Kensington. 

    The hotel is just 2 minutes walk from Gloucester Road tube station for convenient travel to Hyde Park, London Eye, Tower Bridge plus more of London’s top attractions. There are also easy and direct links to some major transport hubs including Victoria, Kings Cross St Pancras, Paddington and Heathrow. 

    This distinctive hotel in south London has so much to offer to make all guests really feel at home. The latest Holiday Inn relaunch is not just about the new look and feel for the hotel but to offer guests more benefits during their stay including a pillow menu for extra comfort during their sleep and a curved shower rail for more spacious feel. 

    In addition to our 906 rooms, all business guests can take advantage of our meeting and conference facilities including High Speed Internet Access and unlimited Starbucks coffee at The Academy. Our hotel’s professional event planners are on board to help take the hard work and stress away from planning your next event. 

    So whether you in London on business or pleasure, make the Holiday Inn London Kensington Forum your first choice of hotel and book your accommodation for our lowest internet rate guarantee. 

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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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    Contact SMi GROUP LTD

    UK Office
    Opening Hours: 9.00 - 17.30 (local time)
    SMi Group Ltd, 1 Westminster Bridge Road, London, SE1 7XW, United Kingdom
    Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
    Website: http://www.smi-online.co.uk Email: events@smi-online.co.uk
    Registered in England No: 3779287 VAT No: GB 976 2951 71




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