Cam2cam with older people
The European Medicines Agency (EMA) plays an important role in ensuring that the needs of older people are taken into account in the development, approval and use of medicines in the European Union.This includes developing guidelines on how to address the specific requirements of older patients in medicine development programmes and improving the provision of information for those patients.The Bill & Melinda Gates Foundation is a Strategic Partner. Not your chronological age (that pesky number on your birthday cake) but how old is the real you, the person inside?In North America, we generally group people into socially constructed age ranges such as: childhood, adolescence, young adulthood, middle adulthood and old age.EMA has also prepared training on how to reflect information targeted at older patients in the summary of products characteristics: When evaluating marketing authorisation applications, EMA's CHMP considers if specific activities concerning aspects such as co-morbidities and the monitoring of specific side effects associated with older patients should be included in the risk management plan or as post-authorisation measures.EMA is also developing a specific module of the guideline on good pharmacovigilance practices (GVP) which will address the specific needs of the geriatric population.It ran a pilot on a dedicated geriatric section in the Day 80 and Day 210 assessment templates with ten new medicines between May 2016 and March 2018.
EMA develops scientific guidelines to help medicine developers address the specific requirements of older people in their medicine development programmes, including in the design and conduct of clinical trials: In addition, EMA encourages medicine developers to address questions on developing medicines for use in the older population as part of scientific advice or in business-pipeline meetings.
Youthful age inside may explain why many older adults want to work past retirement age.
It may impact financial planning: if older adults feel young, they may not be saving money.
This found adequate compliance with international requirements and made recommendations on how to improve the implementation of existing guidelines and update guidelines on the design and conduct of clinical trials: With the aim of improving product information and enabling informed prescription, EMA's CHMP has revised its assessment templates and guidance to assessors to improve clarity of geriatrics-specific issues.
This should help: The CHMP first updated the assessment template with clearer information on the number of elderly people involved in a medicine's clinical-trial programme and side effects in older patients in 2011.