Addressing an Evolving Drug Safety Landscape
Pharma and Biotech organisations are facing growing challenges from the rapidly developing pharmacovigilance landscape:
- Increasing PV regulation
- Expanding inspection scrutiny on non-core areas, such as affiliate practices, patient support programs and sales rep activities
- Aggressively growing volumes of adverse events reported
- Portfolios are becoming increasingly diverse with differing demands
- Patient/consumer expectations are far greater than ever before
These factors, combined with the pressure of cost containment, demand that life science organisations consider different approaches to the traditional, largely manual PV processes.
A risk-based processing approach introduces a highly effective and efficient process to manage drug safety, ensuring quality data is collected across the portfolio:
- New products – Providing fast feedback, as complete as possible, to fuel analytics for informed decisions in a timely & consistent manner.
- Established products – Processing high volumes of data in a compliant, automated manner with an emphasis on product quality.
Are you ready to implement this type of approach to your PV processes? Are you interested in how a risk-based approach could support your scalability and planning for the future?
On Monday 29th February 2016, the Pharmadanmark network for pharmacovigilance has kindly invited MyMeds&Me to come and share their thoughts on the future of pharmacovigilance and how technology can help address the challenges facing PV teams. The presentation will include a review of the current PV landscape and outline how utilizing the latest technology approaches will:
- Generate better and more complete AE data
- Intelligent triage
- Fuel improved RMPs, PSURs and signalling
- Provide greater consistency across affiliates
- Enable greater visibility and systems control
- Gain better product understanding.
Join us on 29th February, network with your PV colleagues and join the discussion. If you are not yet a member of Pharmadanmark, please email us to reserve your place: firstname.lastname@example.org