|By Business Wire||
|January 20, 2014 10:43 AM EST||
Problems with understanding regulatory processes and requirements account for 38% of reported internal communication challenges, finds new Cutting Edge Information research.
The just-launched study, “Pharmaceutical Regulatory Affairs: Arming Regulatory Groups with Voice and Influence to Meet Strategic Challenges,” discovered that regulatory affairs teams may encounter several challenges when interacting with interdisciplinary teams. Among surveyed companies, 48% of the reported difficulties revolve around misunderstanding regulatory requirements and strategy.
“One possible reason for these challenges is that some internal teams may not be aware of how frequently the regulatory environment changes,” said Jacob Presson, research analyst at Cutting Edge Information. “In other cases, a team may think an agency will approve a drug simply because of its clinical benefits, and it may underplay agencies’ priorities around cost-effectiveness and trial design.”
Along similar lines, 11% of communication challenges revolve around issues in understanding regulatory strategy, including submission processes. Some functions may not realize the potential impact of regulatory strategy on product development, market authorization and post-approval marketing. These misconceptions can frustrate all involved and, if managed poorly, become serious impediments to productive cross-functional coordination.
Regulatory affairs teams can correct these misunderstandings through discussions about regulatory guidances, processes and strategy. Regulatory groups offer clarity on current agency guidelines and highlight how they will impact the product’s development. In these discussions, regulatory affairs underlines agency perspectives and priorities to explain why certain guidelines exist.
Beyond emphasizing requirements, regulatory affairs should also communicate the benefits of regulatory strategy to cross-functional teams. Namely, they should emphasize how regulatory strategy increases a product’s chances of entering a market and staying there. Once cross-functional teams understand regulatory strategy and its importance in product development, inter-team communication will ideally improve.
The study “Pharmaceutical Regulatory Affairs: Arming Regulatory Groups with Voice and Influence to Meet Strategic Challenges,” (http://www.cuttingedgeinfo.com/research/regulatory/pharmaceutical-regulatory-affairs/) provides benchmarks and best practices for expanding regulatory affairs’ strategic impact. Backed by quantitative and qualitative research, this study examines regulatory groups’ roles and responsibilities internally and externally. Data include how often regulatory affairs groups meet with internal clients and maintain communication with regulatory agencies.
Use this report to:
- Increase cross-functional communication.
- Redefine regulatory affairs teams’ roles.
- Strengthen relationships with regulatory agencies.
- Improve regulatory spending and activities.
For more information about regulatory affairs benchmarks, contact Cassie Demeter at 919-403-6583.
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