SOURCE: Cutting Edge Information

Cutting Edge Information

February 13, 2015 09:30 ET

Life Sciences Companies Average Fewer Than 3 Formal Meetings With Regulatory Agencies During Each Stage of Clinical Development

Pharmaceutical Regulatory Affairs Groups Should Balance Formal and Informal Interactions to Build Relationships and Understand Agency Needs

RESEARCH TRIANGLE PARK, NC--(Marketwired - February 13, 2015) - Life sciences companies meet with regulatory agencies fewer than three times during each stage of clinical development, according to pharmaceutical intelligence provider Cutting Edge Information. However, pharmaceutical regulatory affairs groups can supplement these meetings with informal communication as long as the communication adheres to agency guidelines. 

Effective communication hinges on insight into the agency. It is crucial for regulatory affairs groups to know the audience within an agency and the circumstances around a situation. Faced with legal and political concerns, agency reviewers do not want to speak on matters they are not prepared to discuss.

"Catching a reviewer off guard is annoying and can lead to foggy guidance," said Jacob Presson, senior research analyst at Cutting Edge Information. "Regulatory affairs teams need to be aware of what topics can appropriately be covered in an informal telephone or email conversation and what requires a formal agency meeting."

According to "Pharmaceutical Regulatory Affairs: Arming Regulatory Groups with Voice and Influence to Meet Strategic Challenges," a benchmarking report by Cutting Edge Information, formal meetings are agenda-driven and require both the agency and the company to prepare specific documentation, thereby limiting the meeting scope. Deviating from the central purpose of these meetings is not typically allowed. While general questions may be easily answered via an informal telephone call or email, agency protocol ultimately determines what can be covered and how.

"Pharmaceutical Regulatory Affairs: Arming Regulatory Groups with Voice and Influence to Meet Strategic Challenges," available at http://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 the regulatory groups' roles and responsibilities. Highlights include:

  • Strategic recommendations to better educate internal teams on regulatory groups' importance.
  • Insights and best practices for improving cross-functional communication throughout the product lifecycle.
  • Steps for gaining a deeper understanding of agency requirements and concerns.
  • Detailed data showing communications between regulatory groups and internal and external teams, as well as budgets and activities supported by regulatory affairs groups.

For more information on "Pharmaceutical Regulatory Affairs: Arming Regulatory Groups with Voice and Influence to Meet Strategic Challenges" and meetings with regulatory agencies, please visit http://www.cuttingedgeinfo.com/research/regulatory/pharmaceutical-regulatory-affairs/.

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