UBC welcomes Haley Kaplowitz as Executive Director of Safety, Epidemiology, Registries, and Risk Management (SERRM). She will provide expertise in product and drug safety, risk management, and pharmacoepidemiology solutions. She will be instrumental in the design and implementation of disease and product registries that meet regulatory requirements and address commercial objectives while examining real-world use of drugs and associated outcomes.
Every year since 2008, Health Network Communications organizes the World Drug Safety Congress to address drug safety and pharmacovigilance challenges. Join me this year in Chicago on April 23 and 24 where, on day one, I’ll be giving a presentation titled, “Safety and Reporting Requirements for INDs and BA/BE Studies.” I’ll be discussing important topics such as:
This year is shaping up to be another exciting one for the UBC team. With nearly 50 conferences already booked for the year, our thought leaders are looking forward to learning, networking, and presenting their work at a host of industry events.
Here is a sampling of our first quarter events. We hope to see you in person very soon!
DIA Pharmacovigilance & Risk Management Strategies: January 25-28, Washington, DC
With sunny 70 degree weather, 40+ museums, 6,400 restaurants, and 92 golf courses, we don’t need to be told twice to travel to San Diego. And this June 16 – 18th we have a great reason to pack our suitcases – the DIA 2014 50th Annual Meeting. UBC is a sponsor of the event (exhibit #923) and we have a number of exciting things planned:
Preparation of REMS Assessment Reports Workshop, Sunday, June 15, 1:00 pm – 4:30 pm
Once a medical product is taken out of a highly controlled clinical environment and is made available through physicians to their patients, additional risks and unknown safety issues may become apparent. Therefore, proactive risk management should begin early in product development. This pre-marketing timeframe offers opportunities to:
In order for biopharmaceutical companies to gain product approval, regulatory agencies first require a series of risk evaluations. Clinical trials, for example, may be utilized in the early phases of development in order to prove a positive benefit-risk assessment. Once the product is approved, however, research is not complete. Products continue to be monitored throughout the lifecycle. In fact, a number of unanticipated/unknown safety issues may be uncovered in this stage. Although it may be impossible to anticipate the exact risks that may arise, companies can – and should – prepare.
The new EU pharmacovigilance legislation (Good Vigilance Practice, GVP) is now in effect and applicants need to be fully compliant. Read UBC's latest article online now at PharmaPhorum.com.
In the gambling world, the number seven is often viewed as lucky, but luck won’t help you prepare for your product’s ongoing safety needs. So, we’ve put together a solid list of seven key questions you should be asking:
1. Is our Pharmacovigilance and Risk Management system ready for product development and launch?
As a resident of Montreal, I’m thrilled that the ICPE (International Conference on Pharmacoepidemiology & Therapeutic Risk Management ) meeting is coming to my city. The conference will be a great opportunity to meet with colleagues from around the world who are committed to an open exchange of scientific information to advance public health and promote research in drug utilization, comparative effectiveness, and therapeutic risk management.