This year’s Promotional Review Committee Compliances & Best Practices East Conference starts today in Morristown, New Jersey, and we hope to see you there. If you’ve followed our blog for a while, you know that we attend several promotional review-specific conferences each year in order to keep up to date on the latest trends and issues our customers face. The upcoming agenda is jam-packed with great speakers and topics. Here’s a few that we’re particularly excited to attend.
Workshop: Learn OPDP Expectations During a Sample Regulatory Review Scenario
Nneka Onwudiwe, PRO/PE Regulatory Review Officer, OPDP, FDA
Keren Tenenbaum, Assistant General Counsel, Pfizer
Cristina Masseria, Methods and Capabilities Lead, Pfizer
This mock review with OPDP professionals provides first-hand exposure to a sample regulatory review, offering a lot of valuable information on expectations and pitfalls as well as the anticipated level of investment in both time and resources required for a successful review. We’re interested to learn more about where life science companies should be focusing their efforts and how our product, Pepper Flow, could help improve the process.
Formalize the Use of References in Promotional Pieces
Jill Charbonneau, Director, Regulatory Affairs, Harmony Biosciences
We know how important claims substantiation is and how hard it can be to ensure accuracy on all of your materials, from speaker decks to digital sales aids. Training your agencies on appropriate reference usage is vital as agency misuse or confusion creates a more protracted review cycle. We look forward to hearing about ways to minimize and correct referencing mistakes, while avoiding additional burden and cost for your agencies.
Panel: The Role of Technology in Submission-Quality Content
Ilyssa Levins, President, Center For Communication Compliance
Dan Heider, Associate Director, Diabetes Payer Brand Marketing, Merck
Thomas Noto, Senior Director, Regulatory Operations, Lexicon Pharmaceuticals
Linda Pissott Reig, Co-chair, Bionj Legal, Compliance, & Regulatory Group; Adjunct Professor, Management And Global Business, Rutgers Business School
Stacy Reese, Director, Regulatory Promotion And Labeling, Teva
MLR review platforms, such as Pepper Flow, have revolutionized the promotional review process. But can we take them a step further? This panel seeks to discuss how life science companies and agencies can better use technology to optimize the quality of materials even before a MLR review begins because life sciences companies can’t afford to lose time and money from a delayed review process. We’re looking forward to hearing this panel discuss use cases and potential pitfalls.
Gather Perspectives and Experience When Reviewing Promotional Websites
Janet Gottlieb, Executive Director, Medical Communications, Allergan
Jimmie Overton, Associate Vice President, Global Medical Scientific Information and Medical Science Library, Allergan
Reviewing interactive content, such as websites, can be challenging when those interactive elements are reduced down PDFs. As we contemplate enhancements to our own treatment of web content in Pepper Flow, we’re interested to hear this team’s pain points and recommended process improvements.
While you’re there, be sure to swing by the Pepper Flow booth and say hello. And if you’ve yet to register, use our sponsor code C1048VODORI to get 15% off.