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P 113 geriatric


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P 113 geriatric

  1. 1. BOOK BY 31ST MAY AND SAVE £300 / BOOK BY 28TH JUNE AND SAVE £100 Register online or fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711 FEATURED SPEAKERS:WHY ATTEND THIS EVENT: • Discover the benefits of performing clinical trials in older people • Identify the key challenges and considerations when conducting clinical trials in older people • Address reasons for clinical trial retention difficulties • Discuss how modelling and simulation along with new patient reporting systems support clinical trials in older people • Explore new market gaps and discover new market strategy • Focus on the EMA geriatric medicines strategy • Solange Rohou, Director of Regulatory Affairs, AstraZeneca • Barbro Westerholm, Member of Parliament, Sweden, Liberal Party Novartis • Michael Richardson, VP International and QPPV EU GPV&E, Bristol Myers Squibb • Eva Bredberg, Director Global Clinical Pharmacology, AstraZeneca • Peter Crome, Professor, Department of Primary Care and Population Health, University College London • Anthea Tinker, Professor of Social Gerontology, Kings College London SMi Presents their Inaugural 16 - 17 SEPT 2013Marriott Hotel, Regents Park, London, UK Geriatric Safe Medicines Summit • Florian Von Raison, Global Programme Head, • Nina Barnett, Consultant Pharmacist,Northwest • Philippe Guillet, Chief Geriatrician,TSU Ageing, Sanofi R&D London Hospitals Trust
  2. 2. Want to know how you can get involved? Interested in promoting your pharmaceutical services to this market? Contact Margaret Mugema, SMi Marketing on +44 (0) 207 827 6072, or email Register online at: • Alternatively fax yo • Pharmacovigilance Specialists • QPPV • Consultant Pharmacologist • Recruitment and Retention Managers • Head of Medicine and Society • Medical Advisor WHO SHOULD ATTEND: 08.30 REGISTRATION & COFFEE 09.00 CHAIRMAN’S OPENING REMARKS: Solange Rohou, Director of Regulatory Affairs, AstraZeneca KEY NOTE 09.10 Patient Perspectives on Healthy Ageing • Most important is to be regarded as a resource, to feel needed • Not to meet ageism/age discrimination • Effective and safe treatment when in need Barbro Westerholm, Member of Parliament, Sweden, Liberal Party Increasing the Representation of Older People in Clinical Trials 09:50 Representation of Older People in Clinical Trials: Results and recommendations of the PREDICT Study • The systematic reviews confirmed the continued unjustified exclusion of older people from clinical trials and that clinicians treating older people and other professional believed that older people were disadvantaged as a result • Focus groups held in the 9 participating countries confirmed that older people and their countries supported a more robust system for including older people in clinical trials Peter Crome, Professor, University College London 10.30 MORNING COFFEE 11.00 Why do older people drop out of longitudinal health studies and how can they be encouraged to continue to participate? • The evidence from longitudinal studies abut older people who drop out of studies • A case study of the Whitehall research on drop out including what would encourage participation • A personal perspective on involvement in 3 longitudinal studies Anthea Tinker, Professor of Gerontology, Kings College London Addressing Adherence Issues 11.40 What can we learn from non adherence in the Clinical Trial • Adherence as a key to achieve the therapeutic outcomes • Reasons for non-adherence: a patient perspective • Understanding non-adherence as a source for product enhancement early on Sven Stegemann, Director, Capsugel 12.20 NETWORKING LUNCH 13.30 A coaching approach to medication adherence • Changing the consultation paradigm - the imperatives • Practical and perceptual approaches to adherence • Coaching and medication adherence • Managing short consultations Nina Lee Barnett, Consultant Pharmacist, Older People North West London Hospitals Trust and E&SE England Specialist Pharmacy Services 14.10 Are low treatment uptake rates due to polymorbidity and polymedication issues: perspectives from the osteoporosis treatment gap in France and the UK. • Evolution of guidelines and clinical practices in the management of osteoporosis • Current osteoporosis guidelines and treatment gap • Reasons for treatment decline, uptake and withdrawal Jonathan Guillemot, Gerontologist, Kings College London 14.50 AFTERNOON TEA 15.20 Can elderly people use new technologies to record their own data? • Where are we with ePRO in general, and specifically with elderly? • What is our experience with elderly? • What is to be considered in Clinical Trials with elderly when they have unsupervised data collection? • Case studies Valdo Arnera, General Manager, PHT Corp 16.00 Formulation development of orally disintegrating tablets: An opportunity to address swallowing difficulties in geriatric patients • The formulation approaches used to overcome medication non adherence in geriatric patients and the paradigm of patient-centered dosage forms • The emerging pharmaceutical orally disintegrating dosage forms and their significance in the increasingly ageing society • Various technologies and cost-effective strategies for orally disintegrating tablet formulation • Novel atomic force microscopy applications which provide an insight into molecular aspects of orally disintegrating tablets formulation development Ali Al-Khattawi, Researcher in Pharmaceutical Sciences/Drug Delivery, Aston University 16.40 Chairman’s Closing Remarks and Close of Day One • Program Heads • Clinical Trial Design Manager • Gerontologists • Geriatrician • Clinical Trials Manager • Academics DAY ONE | 16TH SEPTEMBER 2013 Geriatric Safe Medicines Summit Supported by • Research Scientists • Pharmaceutical regulators • Stakeholders and those with an interest in Geriatric medicine
  3. 3. our registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711 DAY TWO | 17TH SEPTEMBER 2013 08.30 REGISTRATION & COFFEE 09.00 CHAIRMAN’S OPENING REMARKS: Solange Rohou, Director of Regulatory Affairs, AstraZeneca Improving Safety Within Geriatric Clinical Trials 09.10 Geriatric Syndromes: What are they? Why do they matter? • Old Old Adults (75+) is the fastest growing segment of population • Old Old subject to specific Geriatric Syndromes (Frailty, Delirium,...), which change the way acute situations manifest themselves (including drug effects and toxicities), needing specific screening, diagnosis & treatment approaches 09.50 Modelling & simulation to support evaluation of safety and efficacy of drugs in older patients • Strategic considerations in drug development regarding the elderly • Changes in PK and PD with age • What value can M&S provide to improve understanding of risk benefits in older people? • Two examples from AstraZeneca Eva Bredberg, Director Global Clinical Pharmacology, AstraZeneca 10.30 MORNING COFFEE 11.00 What has been done since the revision of the ICH E7 guideline? The Companies' view • The revision of ICH E7 • EFPIA interactions at the workshop organised by the EMA in March 2012 • How to optimise clincial development in the elderly? • What companies are planning/doing to collect data in this special growing population Solange Rohou, Director Regulatory Affairs, AstraZeneca 11.40 Early identification of co-morbidities and the challenges of prescribing in this patient population due to drug- drug interactions • Cognitive impairment as a barrier to treatment • The impact of co-mobidities on a Clinical Trial • Developing effective patient reporting systems as a way to improve patient compliance Mark Baxter, Geriatric Consultant, Spire Sussex Hospital 12.20 NETWORKING LUNCH Importance of Guidance on Medical Research in Geriatric Patients 13.30 Proposal for guidance on medical research for and with older people in Europe • There is an evident lack of consistent ethical guidance on medical research for and with older people in Europe • Workshops with stakeholders from academia, investigators, patient representatives and pharma were held to develop a consensus on principals • The aim of the guidance is to facilitate clinical research for and with the older patient population Florian Von Raison, Global Program Head, Novartis Pharma 14.10 Information for rational drug prescribing to older patients - from pre-authorisation to post-marketing • Older patients in pre-authorisation trials – number, exclusion criteria and representability • Available information for adequate prescribing to older patients – product information and handbooks • What information for adequate prescribing about older patients is needed? – views of clinical and non-clinical professionals Erna Beers, MD, Clinical Pharmacologist, UMC Utrecht 14.50 AFTERNOON TEA 15.20 Effective risk-management planning in older people • Effectiveness of post-authorisation studies • Important considerations in prescribing • Predicting adverse drug reactions: Key predictor outcomes Michael Richardson, VP International and QPPV EU GPV&E, Bristol Myers Squibb 16.00 The use of body monitoring devices to monitor Geriatric drug absorption rates • Body monitoring devices as a useful tool to detect absorption rates • Assessment of patient reaction to drug substances • Body monitoring devices: an effective effective method of assessing in real-time a patients reaction to dosage forms Jean Cuine, Chief Scientific Officer, NextPharma 16.40 Chairman’s Closing Remarks and Close of Day Two Geriatric Safe Medicines Summit SPONSORSHIP AND EXHIBITION OPPORTUNITIES SMi offer sponsorship, exhibition, advertising and branding packages, uniquely tailored to complement your company's marketing strategy. Should you wish to join the increasing number of companies benefiting from sponsoring our conferences please call: Anuja Raut, SMi Sponsorship on +44 20 7827 6128 or email: SMi PHARMACEUTICALS FORWARD PLANNER 2013 MAY Generics, Supergenerics and Patent Strategies 13 - 14 May 2013, London Pain Therapeutics 20 - 21 May 2013, London ADC Summit 20 - 21 May 2013, London Clinical Trial Logistics 22 - 23 May 2013, London JUNE RNAi & Nanotechnology 5 - 6 June 2013, London Biobanking 24 - 25 June 2013, London JULY Pharmacovigilance 1 - 2 July 2013, London Cell Culture 3 - 4 July 2013, London ADMET 10 - 11 July 2013, London SEPTEMBER Cancer Vaccines 18 - 19 September 2013, London OCTOBER Biosimilars & Biobetters 1 - 2 October 2013, London Diabetes 1 - 2 October 2013, London Orphan Drugs 14 - 15 October 2013, London COPD: Novel Therapeutics and Management Strategies 16 - 17 October 2013, London European Pharmaceutical Pricing & Reimbursement 21 - 22 October 2013, London Point of Care Diagnostics - Market Opportunities and Technology Trents 23 - 24 October 2013, London NOVEMBER Cell Based Assays 18 - 19 November 2013, London Clinical Trials in CNS 18 - 19 November 2013, London DECEMBER Cold Chain Distribution 3 - 4 December 2013, London Philippe Guillet, Ageing Therapeutic Strategic Unit, Sanofi
  4. 4. GERIATRIC SAFE MEDICINES SUMMIT Conference: Monday 16th and Tuesday 17th September 2013, Marriott Hotel, London, UK 4 WAYS TO REGISTER FAX your booking form to +44 (0) 870 9090 712 PHONE on +44 (0) 870 9090 711 POST your booking form to: Events Team, SMi Group Ltd, 2nd Floor South, Harling House, 47-51 Great Suffolk Street, London, SE1 0BS, UK If you have any further queries please call the Events Team on tel +44 (0) 870 9090 711 or you can email them at Payment: If payment is not made at the time of booking, then an invoice will be issued and must be paid immediately and prior to the start of the event. If payment has not been received then credit card details will be requested and payment taken before entry to the event. Bookings within 7 days of event require payment on booking. Access to the Document Portal will not be given until payment has been received. 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Due to the interactive nature of the Briefings we are not normally able to providedocumentationinthesecircumstances.Wecannotacceptcancellationsofordersplaced forDocumentationortheDocumentPortalasthesearereproducedspecificallytoorder.Ifwehave to cancel the event for any reason, then we will make a full refund immediately, but disclaim any further liability. Alterations: It may become necessary for us to make alterations to the content, speakers, timing, venue or date of the event compared to the advertised programme. Data Protection: The SMi Group gathers personal data in accordance with the UK Data Protection Act1998andwemayusethistocontactyoubytelephone,fax,postoremailtotellyouaboutother productsandservices.Unlessyoutickhere□ wemayalsoshareyourdatawiththirdpartiesoffering complementary products or services. If you have any queries or want to update any of the data that we hold then please contact our Database Manager or the attached letter. 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