Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at email@example.com if you need assistance.
The site navigation utilizes arrow, enter, escape, and space bar key commands. Left and right arrows move
across top level links and expand / close menus in sub levels. Up and Down arrows will open main level
menus and toggle through sub tier links. Enter and space open menus and escape closes them as well. Tab
will move on to the next part of the site rather than go through menu items.
The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
With so many global regulation changes, staying informed is a challenge. Join other regulatory professionals as you navigate the gray together.
For 20 years, our flagship publication, Fundamentals of US Regulatory Affairs, has been giving regulatory professionals the insights and answers they need, right at their fingertips.
There are hundreds of RAC testing centers available worldwide. Any of the four RAC exams (US, EU, CAN or Global) may be taken at any location. Find an upcoming exam at a location near you.
Posted 10 April 2012 | By Alexander Gaffney, RAC
The European Medicines Agency (EMA) held a two-day workshop in March 2012 on the use of medicines in older persons.
The workshop saw 34 presentations covering a wide range of perspectives on the subject, including EMA's geriatric strategy, conducting clinical trials, pharmacovigilance, ensuring safety and efficacy of medicines through modeling and more.
Those presentations may be found in the links below.
European Medicines Agency workshop on medicines for older people
European Medicines Agency workshop on medicines for older people - Invitation for expressions of interest
Programme - European Medicines Agency workshop: Ensuring safe and effective medicines for an ageing population
Presentation - EMA Geriatric medicines strategy, Francesca Cerreta
Presentation - Healthy ageing and medicines the patients perspective of ageing, Barbro Westerholm
Presentation - The industrys views on geriatric medicines, Jean-Pierre Lehner
Presentation - ICH E7 requirements and how they are translated in practice, Kristina Dunder
Presentation - Elderly patients and clinical trials, Bertil Jonsson
Presentation - Can PK and modelling help?, Terry Shepard
Presentation - Modelling and simulation to support evaluation of safety and efficacy of drugs in older patients, Eva Bredberg
Presentation - How to get better data on medicines post licensing, Thomas MacDonald
Presentation - Endpoints and their relevance to older people: cancer and palliative care and work of EORTC, Ulrich Wedding
Presentation - Endpoints and indications for the older population, William Evans
Presentation - Frailty: Challenges and possible solutions, Niccolo Marchionni
Presentation - The cluster medicine approach, Alessandra Marengoni
Presentation - The industrys views on "older" old patients, Susanna Del Signore and Philippe Guillet
Presentation - Increasing enrolment in clinical trials and the PREDICT study, Antonio Cherubini
Presentation - Efficacy and effectiveness models, Graziano Onder
Presentation - Proposal for guidance on medical research for and with older people in Europe, Florian Von Raison
Presentation - Practical proposals on recruitment improvement: R&D approach and focus on possible bottleneck issues, Brigitte Stemper
Presentation - Medication Errors & STOPP/START criteria, Denis O'Mahony
Presentation - Predictors of outcome and renal clearance, Ulf Bergman
Presentation - Pharmacovigilance and the elderly, Dolores Montero
Presentation - EudraVigilance and signal detection, Georgy Genov
Presentation - Industry perspective, Michael Richardson
Presentation - Pharmacovigilance in the elderly: Conclusions, Peter Arlett
Presentation - Formulations, packaging and medication practices considerations, Michael J. Theodorakis and Adalsteinn Gudmundsson
Presentation - Industry perspective on formulation and packaging considerations, Ronald Ogilvie
Presentation - What do we need to consider to ensure medication adherence of older adults, Sven Stegemann
Presentation - Providing information to the older population - Understanding the needs of older people, Jean-Pierre Baeyens
Presentation - A NCA analysis of approval documents, Paul Jansen
Presentation - How can SmPC and EPAR information contribute to the safe and effective use of medicines in older population?, Laurent Brassart
Presentation - Package leaflet initiatives, Alexios Skarlatos
Presentation - Providing information to the older population, an industry perspective, Lisette Vromans
Presentation - Conclusions, Tomas Salmonson, June Raine
Tags: Older, Workship, Elderly, Geriatric, Latest News, medicines, clinical trials
Regulatory Focus newsletters
All the biggest regulatory news and happenings.