- Guest blog by Roger Morris, The LondonBritain Company -
Having worked in communications in the pharmaceutical industry for more than 25 years, I continue to be amazed at how even strong competitors remain so open to sharing information and experiences. Perhaps it’s the academic nature of pharmaceutical research that filters out to everyone else in the business, but the industry is constantly talking within itself – from scientific publications about new compounds to physician disease-state annual meetings to specialty conferences.
All this is to draw attention to an important upcoming conference on REMS being held in less than two weeks – February 16 at the Park Hyatt Hotel in Washington – by the Food & Drug Law Institute. If you aren’t familiar with the FDLI, it’s a great third-party resource, and the people at ParagonRx have partnered with them on several occasions to co-sponsor such conferences and to publish the two primary source books about REMS.
This conference will address “Emerging Realities in REMS Planning and Execution” and it will have FDLI’s traditional mix of speakers and panel members – selected officials of the FDA, representatives of the Washington legal firms that work on regulatory matters with the drug industry and pharmaceutical company executives who have strong experience with REMS planning and implementation.
Wayne Pines, the venerable pharmaceutical consultant and former FDA executive, will serve as chair. One of the primary speakers will be ParagonRx Chief Medical Officer, Gary Slatko, MD, who will address REMS lifecycle management. It is a topic that Gary is well-suited to discuss, as he has worked with more pharmaceutical companies on more REMS programs than anyone else at the conference – with the exception of the FDA participants, of course! Of all the REMS meetings that have been held, a key to this one is that it probably represents the best mix of planning strategy and hands-on execution of any to date. I hope you can attend. For more information and to register, please go to http://www.fdli.org/conf/10/rems/.
If you can’t make, I will be blogging from the conference. And please check back with us to see further analysis, even if you attend.
See you in Washington.
– Roger