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Age demographics are shifting in both the developing and developed world. Higher standards of living, better health care and the implementation of welfare systems all contribute to increased longevity, but with an ever growing older population health burdens are shifting and the treatment of age related disease conditions is increasing. The challenges involved in the treatment of the older patient are numerous. Co-morbidities, lack of clinical trial data on the target population, challenges of drug-drug interactions, compliance and a number of ethical issues surrounding the treatment of the older population are all concerns of those working within geriatric medicine.

Join SMi for their inaugural Geriatric Safe Medicines Summit as they seek to address these issues and many more in what promises to be a highly thought provoking and stimulating event.
 

How do we overcome the challenges of under-representation of a target patient population in a clinical trial for which the drug is intended for use in, and what are the ethical dilemas involved in the participation of the older population in clinical trials. Discover the latest and future changes in regulations surrounding the safe use of medicines in older people and how companies can apply these to future clinical trials.

Discuss the approach regulatory bodies have towards the treatment of the older population 

Discover how to demonstrate safety and efficacy in the older population

Address formulation and compliance issues 

Assess  pharmacovigilance practices  

Review the role regulatory agencies have in ensuring information is appropriately communicated to the older population

This Conference is a must attend event for the following:

Pharmacovigilance Specialists

QPPV

Gerontologists

Geriatrician

Clinical Trials Manager

Academics

Research Scientists

Pharmaceutical regulators

Stakeholders and those with an interest in Geriatric medicine

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Solange Rohou

Solange Rohou Director Regulatory Affairs, AstraZeneca

9:50 Patient perspectives on healthy ageing

Barbro Westerholm

Barbro Westerholm Member of Swedish Parliament, Swedish Parliament

  • 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
  • 10:30 Morning Coffee

    11:00 Representation of Older People in Clinical Trials: Results and Recommendations of the PREDICT Study

    Peter Crome

    Peter Crome Professor, Univeristy College London Hospitals

  • The systematic reviews confirmed the continued unjustified exclusion of older people from clinical trials an that clinicians treating older people and other professionals 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 
  • 11:40 Why do older people drop out of longitudinal health studies and how can they be encouraged to continue to participate?

    Anthea Tinker

    Anthea Tinker Professor at the Institute of Gerontology, Kings College London

  • The evidence from longitudinal studies about older people who drop out of studies
  • A case study of the Whitehall research on drop outs including what would encourage participation
  • A personal perspective on involvement in 3 longitudinal health studies
  • 12:20 Networking Lunch

    13:30 What can we learn from non adherence in clinical trials

    Sven Stegeman

    Sven Stegeman Director, Capsugel (Warner-Lambert)

  • Adherence as a key to acheive therapeutic outcomes
  • Reasons for non-adherence: a patient perspective
  • Understanding non-adherence as a source early on
  • 14:10 A coaching approach to medication adherence

    Nina Lee Barnett

    Nina Lee Barnett Consultant Pharmacist, North West London Hospitals

  • Chnaging the consultation paradigm- the imperatives
  • Practical and perceptual approaches to adherence
  • Coaching and medication adherence
  • Managing short consultations
  • 14:50 Are low treatment uptake rates due to polymorbidity and polymedication issues: perspectives from the osteoporosis treatment gap in France and the UK

    Jonathan Guillemot

    Jonathan Guillemot PhD Student, Kings College University

  • Evolution of guidelines and clinical practices in the management of osteoporosis
  • Current osteoporosis guidelines and treatment gaps
  • Reasons for treatment decline, uptake and withdrawal
  • 15:30 Afternoon Tea

    16:00 Formulation development of orally disintegrating tablets: An opportunity to address swallowing diffculties in Geriatric Patients

    Ali Al-Khattawi

    Ali Al-Khattawi Researcher in Pharmaceutical Sciences/Drug Delivery, Aston University

  • The formulation approaches used to overcome medication non-adherence in geriatric patients and teh paradigm of patient-centred dosage forms
  • The emerging pharmaceutical orally disintegrating dosage forms and their signficance in the increasing 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 tablet formulation development
  • 16:40 New approaches to improved adherence: pharmacy-level “PolyPill” assembly

    Mark Wilson

    Mark Wilson Director, Collaboration Management, Pharmaceutical Development Division, GlaxoSmithKline plc

  • The assembly at the pharmacy of so-called “polypills”, which contain multiple drug compounds, provides the possibility to improve adherence through the provision to patients of medicines that are specific to the individual
  • Each tablet may be adapted to the individual’s required dosing regimen, so that a patient may be provided with a weekly-pack and required to take only one tablet on each dosing occasion
  • This reduced “pill burden” may improve adherence, with beneficial effects on healthcare outcomes, especially among elderly patient groups
  • This late-stage manufacturing approach obviates the need for high stock and inventory levels throughout the supply chain, which some sources cite as a drawback to the widespread adoption of combination tablets
  • The talk will describe one company’s work to develop a technology that would facilitate such an approach to pharmacy-level “polypill” assembly.
  • 17:20 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Solange Rohou

    Solange Rohou Director Regulatory Affairs, AstraZeneca

    9:10 Geriatric Syndromes: What are they and why do they matter?

    Philippe Guillet

    Philippe Guillet Chief Geriatrician, TSU Ageing, Sanofi R&D

  • Old old adults (75+) is the fastest growing segment of the population
  • Old old subject to specific geriatric syndromes (Frailty, delirium...) which can change the way acute situations manifest themselves (including drug effects and toxicities), needing specific screening, diagnosis and treatment approaches
  • 9:50 Modelling and simulation to support evaluation of safety and efficacy of drugs in older patients

    Rene Bouw

    Rene Bouw Section Director Clinical Pharmacology Scientists, AstraZeneca

  • Strategis considerations in drug development regarding the elderly
  • Changes in PK and PD with age
  • What value can M&S provide to improve the understanding of risk benefits in oler people?
  • Two examples from AstraZeneca
  • 10:30 Morning Coffee

    11:00 What has been done since the revision of the ICH E7 guideline? The Companies’ view

    Solange Rohou

    Solange Rohou Director Regulatory Affairs, AstraZeneca

  • 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
  • 11:40 Early identification of co-morbidities and the challenges of prescribing in this patient population due to drug-drug interactions

    Mark Baxter

    Mark Baxter Geriatric Consultant, University Hospitals Southampton

  • 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
  • 12:20 Networking Lunch

    13:30 Proposal guidance on medical research for and with older people in Europe

    Florian Von Raison

    Florian Von Raison Senior Global Program Head, Novartis

  • There is an evident lack of consistent ethical guidance on medical research for and with older people in Europe
  • Workshops from stakeholders from academia, investigators, patient representatives and pharma were held to develop a consensus on principals
  • The aim of the guidance is to facilitate clinial research for and with the older patient population
  • 14:10 Information for rational drug prescribing to older patients- from pre-authorisation to post-marketing

    Erna Beers

    Erna Beers MD Clinical Pharmacologist, UMC Utrecht

  • Older patients in pre-authorisation trials- number, exclusion criteris 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 a clinical and no clinical professional
  • 14:50 Afternoon Tea

    15:20 Effective risk management planning in older people

    Michael Richardson

    Michael Richardson VP International and QPPV EU GPV&E , Bristol Myers Squibb

  • Effectiveness of post-authorisation studies
  • Important considerations in prescribing
  • Predicting adverse drug reactions: Key predictor outcomes
  • 16:00 Research in complex elderly patients (Stroke), reality vs practicality

    Amit  Mistri

    Amit Mistri Consultant in Stroke Medicine, University Of Leicester

  • What is the age distribution in clinical trials involving stroke patients?
  • How does this compare with real-life populations?
  • What is the applicability of these results?
  • 16:40 Chairman’s Closing Remarks and Close of Day Two

    +

    FEATURED SPEAKERS

    Barbro Westerholm

    Barbro Westerholm

    Member of Swedish Parliament, Swedish Parliament
    Nina Lee Barnett

    Nina Lee Barnett

    Consultant Pharmacist, North West London Hospitals
    Solange Rohou

    Solange Rohou

    Director Regulatory Affairs, AstraZeneca

    Ali Al-Khattawi

    Researcher in Pharmaceutical Sciences/Drug Delivery, Aston University
    Ali Al-Khattawi

    Amit Mistri

    Consultant in Stroke Medicine, University Of Leicester
    Amit  Mistri

    Anthea Tinker

    Professor at the Institute of Gerontology, Kings College London
    Anthea Tinker

    Barbro Westerholm

    Member of Swedish Parliament, Swedish Parliament
    Barbro Westerholm

    Erna Beers

    MD Clinical Pharmacologist, UMC Utrecht
    Erna Beers

    Florian Von Raison

    Senior Global Program Head, Novartis
    Florian Von Raison

    Irene Garcia-Bravo

    Project Manager, European Medicines Agency (E M E A)
    Irene Garcia-Bravo

    Jonathan Guillemot

    PhD Student, Kings College University
    Jonathan Guillemot

    Mark Baxter

    Geriatric Consultant, University Hospitals Southampton
    Mark Baxter

    Mark Wilson

    Director, Collaboration Management, Pharmaceutical Development Division, GlaxoSmithKline plc
    Mark Wilson

    Michael Richardson

    VP International and QPPV EU GPV&E , Bristol Myers Squibb
    Michael Richardson

    Nina Lee Barnett

    Consultant Pharmacist, North West London Hospitals
    Nina Lee Barnett

    Peter Crome

    Professor, Univeristy College London Hospitals
    Peter Crome

    Philippe Guillet

    Chief Geriatrician, TSU Ageing, Sanofi R&D
    Philippe Guillet

    Rene Bouw

    Section Director Clinical Pharmacology Scientists, AstraZeneca
    Rene Bouw

    Solange Rohou

    Director Regulatory Affairs, AstraZeneca
    Solange Rohou

    Sven Stegeman

    Director, Capsugel (Warner-Lambert)
    Sven Stegeman

    VENUE

    Marriott Regents Park

    128 King Henry's Road, London, United Kingdom

    This 4 star north London hotel in zone 2 is the perfect destination for the astute business traveler as well as the leisure guest that knows how convenient north London hotels are, as a base from which to explore the city .Bond Street is just 3 stops from Swiss Cottage underground station on the Jubilee Line, so you can be shopping, exploring the sights and taking in one of London’s world-renowned West End shows in less than 15 minutes when you stay at this hotel near central London. At the same time, the hive of activity that is Camden Town, the chic shops, cafes and restaurants of Primrose Hill and ZSL’s London Zoo in Regents Park are all just a short walk from this hotel in north London.

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    Marriott Regents Park

    128 King Henry's Road
    London NW3 3ST
    United Kingdom

    Marriott Regents Park

    This 4 star north London hotel in zone 2 is the perfect destination for the astute business traveler as well as the leisure guest that knows how convenient north London hotels are, as a base from which to explore the city .Bond Street is just 3 stops from Swiss Cottage underground station on the Jubilee Line, so you can be shopping, exploring the sights and taking in one of London’s world-renowned West End shows in less than 15 minutes when you stay at this hotel near central London. At the same time, the hive of activity that is Camden Town, the chic shops, cafes and restaurants of Primrose Hill and ZSL’s London Zoo in Regents Park are all just a short walk from this hotel in north London.

    HOTEL BOOKING FORM

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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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