Medical devices and pharmaceutical care 2014 N.42

•Download as DOC, PDF•

0 likes•256 views

Medical devices and pharmaceutical care specialists provide consultation services on device classification, coding, legislation, alternatives, logistics, and in vitro diagnostic product management. They also monitor budget impact, appropriate usage, device interactions, train medical teams, support device surveillance, facilitate communication between wards and central pharmacy departments.

Medical devices and pharmaceutical care
Today vs past more incidence on health care organization and hospital cost - budget impact
Medical devices pharmacist specialist
Consultant activities, property, classification, codification, legislation
Alternative products, logistic
In vitro diagnostic products management
Budget departement control, monitoring , Appropriateness use
Interaction ( vs other medical devices, Drugs and other products or diagnostic procedures )
Training to medical team
Medical devices surveillance : specialistic support
Turnover ward stokes
Facilitator role : between ward team and the central pharmacy

Pharmaceutical and medical device manufacturers are expected to capture all mentions of adverse events in the literature as soon as they are published. Failure to identify an event comes with high costs—including hefty fines from regulatory authorities and potential damage to the company’s reputation. Strategies for monitoring the ever-increasing amount of biomedical literature must be designed for huge volumes of data, and companies need to have a system in place to proactively identify reliable reports and accurately judge their importance. Having the full range of necessary information also enables research teams to make thorough drug safety assessments, improve study design and regulatory applications and, ultimately, to make better-informed risk management and mitigation decisions.

New EU PV regulationsDr.Vijay Talla

Pharmacovigilance Basics for fresher's as well as experience candidates

Jonaid Ali

The prescription drug sales have been growing globally at a rate of 12-20%, which is lucrative by any standards, especially when top companies’ total sales are approaching 25-40 billion USD a year. Such market forces create tremendous pressure on one side on the drug sponsors to launch their product as early as possible, and on the other hand on the significantly regulators to decide on the product safety for approval with a tremendous time constraint. In such a scenario, drug regulatory authorities in US, Europe and elsewhere have renewed their mandate to fortify the “safety” regulations so that the drugs released to the market are highly safe and effective. The FDA Amendment Act, 2007 (FDAAA) have now authorized FDA to significantly increase the user fees for safety initiatives and evaluations. The FDA initiatives include its authority to ask from a drug sponsor a Risk and Evaluation Mitigation Strategy (REMS) with a detailed risk minimization action plan. FDA can now require the sponsor to develop a comprehensive safety surveillance system as well. For each new drug, FDA will now also establish an internal committee for a safe use of this drug in pediatric population. Similar approaches and authorities have also been given to European drug regulatory agencies. This presentation will take you through the current proactive risk management approaches used or proposed by the prominent regulatory agencies for both pre- and post- market safety surveillance of new drug and new drug products. It will also discuss the challenges and collaborative efforts of both regulators and industry to work with a multidisciplinary safety management system to identify and assess the risk signals as early as possible in drug development process. Further it will discuss the reporting and evaluation of this data such that it helps pre-market approval of the safest possible product and a transparent post-market surveillance plan.

Periodic Safety Update Report (PSUR)

Dr. Rohith K Nair

Good Pharmacovigilance Practices

sopi_1234

Jornadas #PatientInHTA · Iñaki Imaz

Instituto Aragonés de Ciencias de la Salud - IACS

Paediatric committee

EURORDIS Rare Diseases Europe

Pharmacovigilance

Wallace Macindoe PhD MBA

The competitiveness of drug development has been the impetus for new and accelerated regulatory pathways. While the growing patient-centric healthcare market coupled with a vested interest in safety information from a range of governmental and regulatory stakeholders has driven pharmacovigilance to reach a new paradigm in drug development. The consequence of which has led to tighter post-marketing surveillance systems on the global scale and a rapidly expanding volume of reported safety events impelling the industry to adopt new strategies to managing pharmacovigilance throughout the product lifecycle. In view of all these changes, it is timely to provide an overview on the concept of Pharmacovigilance, and here i3 Consult has published in this Slide Share, some key topics on Pharmacovigilance such as Signal Detection, Detection Management, Risk Management and Risk Reduction Strategies. At i3 Consult, our core team of experts & our 200,000+ network bring innovative ideas, cost effective solutions and game changing services to healthcare, pharma & life science, for more details, visit www.i3consult.com

Post marketing surveillance

suraj mungase

Challenges In Pharmacovigilance Dr Vishwas, by Dr. Vishwas Sovani MD ,VP P...Until ROI

Literature monitoring for pv what are we doing at galderma elsevier webinar

Ann-Marie Roche

Committee for Advanced Therapies

EURORDIS Rare Diseases Europe

PDF- 12BOOK MLCF -extended version - MEMBERSHIP- quinta EDIZONE- La gia’ den...

Medical devices and pharmaceutical care 2014 N.42

Recommended

Recommended

More Related Content

What's hot

What's hot (20)

More from M. Luisetto Pharm.D.Spec. Pharmacology

More from M. Luisetto Pharm.D.Spec. Pharmacology (20)

Medical devices and pharmaceutical care 2014 N.42