With constantly evolving FDA regulations, it is becoming difficult for pharmaceutic al companies to create and maintain complian t labels. From creating content to effectively managing submissions and changes, the labeling process is becoming more complex with so many companies beginning to market their products globally .
Pharmaceutical c ompanies are finding it increasingly important to document core content of labels in th eir company core data sheets to direct local affiliate labeling more efficiently. Roya Be h bahani, Senior Director, Labeling Strategy at GlaxoSmithKline and speaker at th e upcoming Pharma Labeling Compliance Conference provided her expertise working with global affiliates and core data sheet management in an exclusive one - on - one interview with marcus evans. The responses below strictly reflect the views a nd beliefs of Roya Behb ahani and not necessarily those of GlaxoSmithKline .
marcus evans: What was the main factor that sparked your interest in participating in this year’s Pharma Labeling Compliance Conference?
RB: My colleague partici pated in the 2013 Pharma Labeling Compliance Conference and thought it provided a great opportunity to interact with colleagues from other companies and exchange best practices across all labeling compliance issues that we deal with on daily basis. I was e xcited to see topics on this year’s conference that are very relevant to my every day work at GlaxoSmithKline.
marcus evans: Working with global affiliates is a major priority of this year’s delegation. What critical information must be included in core da ta sheets to facilitate an efficient working relationship with affiliates?
RB: It’s important to consider what core information need s to be included in every local country label from the core data sheet , versus those that are up to the local affiliates to decide based on their local regulations. It ’s also very important that a level of priority is given to each update from the core data sheet, so the global affiliates know the priority for updating their local labels . F or example , a major safety informatio n update should get a priority level that affiliates recognize for filling in their local countries.
marcus evans: What processes have you put in place to assist global affiliates with implementing core data into their labels
RB : At GlaxoSmithKline, we have many processes in place to help global affiliates with implementing core data information in their local labels. We also have a very comprehensive way of dispatching core data sheet updates to all LOCs . There is also a process that outlines the level of importance of each update and the timeframe requirement by each LOC to file in their local countries. Not all updates to the core data sheet require the same timelines .
marcus evans: What are some of the key challenges you’ve faced when integrating glo bal regulations into core data sheets? How have you overcome these challenges?
RB: We try to avoid using specific local regulations in the core data sheet as much as possible . If there is something that is only to satisfy one region, then we make sure not to require that as core information, so not all other countries need to implement. For example, we don’t put any pregnancy category in the core data sheet as that is only for use in the U . S.
marcus evans: Is there a particular approach you’ve found to be most effective in the development and management of core data sheets? Please explain.
RB: Yes, we have found it’s important for the teams to understand the process for developing and updating the core data sheet. We also try to develop our core data shee t in parallel to the major local labels such as US PIs and SmPCs, so the teams can understand and distinguish between what is our company position and what may need to be adjusted based on local regulatory requirements.
Roya Behbahani will be covering the s ession. “Developing a Core Data Sheet that will Facilitate the Creation of Local Labels,” at the 2 nd Annual Pharma Labeling Compliance Conference , March 19 - 20, 2014 in Boston, MA.
For more information , please contact Robin Yegelwel, Marketing & PR Coordinator, at (312) 540 - 3000 ext. 6483 or robiny@marcusevansch.com
About Roya Behbahani, PharmD , MBA
Roy a Behbahani received her PharmD from the Philadelphia College of Pharmacy and Science. After receiving her degree, Roya completed a fellowship in Pharmacokinetics and received her MBA from Regis University in Denver, Colo.
Roya has been with Glaxo SmithKline for the past 18 years and has held several positions within the medical information department and labeling groups. Prior to her position at GlaxoSmithKline, Roya worked as a C linical Pharmacist at Cooper Hospital in Camden, New Jersey and an Adjunct Professor at Philadelphia College of Pharmacy and Science.
About marcus evans
marcus evans conferences annually produce over 2,000 high quality events designed to provide key str ategic business information, best practice and networking opportunities for senior industry decision - makers. Our global reach is utilized to attract over 30,000 speakers annually; ensuring niche focused subject matter presented directly by practitioners an d a diversity of information to assist our clients in adopting best practice in all business disciplines.
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