Medicines for older adults: | CN 6704Getting Prepared for the scientific and regulatory evolution
VenueTechnische Universität Graz
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Workshop programme for download
Increasing life expectancy and longevity is leading to significant change in future patient populations challenging the traditional drug development
and healthcare provision. The majority of patients in primary care will be characterized by very high age, multimorbidity and polypharmacy living and managing their therapy independently or with the support of care giving relatives.
This trend has recently been recognized by healthcare professionals as
well as the European Medicines Agency (EMA). The latter one brought
forward a Geriatric Medicines Strategy Roadmap 2015 and will shortly publish
a Reflection Paper on quality aspects for medicines for older people. In addition the FDA and EMA have released guidance concerning considerations for product design to minimize medication errors that also addressed the diversity of the different end-user groups (geriatric, pediatric populations etc.)
Traditionally drug product development is very much focused on the physico-chemical properties and biopharmaceutical performance of the drug product to achieve the therapeutic outcomes in the clinical trials. When facing the real world patient populations with age related impairments, multimorbidity and complex medication schedules the therapeutic outcomes, so called effective-
ness, often fall short on expectations. There is increasing evidence that poor adherence, medication errors, difficulties in managing, handling and administering the existing drug products are major root causes.
Patient centric pharmaceutical drug product development and design to address the needs of patient will become the next quantum leap to enhance effectiveness, health outcomes and quality of life for older patients. Under-standing the characteristics patient population and including these in the Targeted Quality Product Profile (TQPP) will effectively guide drug product development towards patient centric drug product. Patient centric drug product development and design has the objective to facilitate the inde-
pendent medication management by the patient, improve adherence, drug safety, effectiveness and as such reduce the overall healthcare costs.
This interactive workshop aims to provide understanding of the older and multi-morbid patient population, up-date on the emerging regulations on medicines development for older people, provide a process to develop age and patient centric drug products as well as discuss potential drug product solutions and opportunities for the pharmaceutical industry.
|Students (full time)||178.00 €|