Handling Regulatory Challenges: Responding With Grace Under Pressure

Posted 26 January 2016 | By Nancy Singer, JD, LLM 

Handling Regulatory Challenges: Responding With Grace Under Pressure

Everyone who chooses a regulatory career learns that it comes with some challenges, and the solutions are not always clear or easy. For a session at the RAPS 2015 Regulatory Convergence in Baltimore last October, Daniela Drago, PhD, who heads up the regulatory affairs program at the George Washington University School of Medicine and Health Sciences, decided to examine some of these challenges with a panel of seasoned regulatory professionals using an interactive audience-participation format.

Drago recruited panelists Linda Bowen, Michael Morton, Ranier Voelksen and Bob Yocher to share their experiences and insights on dealing with some tricky situations. She showed attendees a series of slides describing various challenging situations, and had them break into small groups to discuss and select from among four proposed solutions. Afterward, the expert panelists provided their perspectives and comments.

Attendees’ feedback on this unique session was overwhelmingly positive and most agreed that it was interesting, relevant to their work and highly engaging. RAPS Senior Manager of Chapter and Account Relations Wesley Carr and Director of Stakeholder Engagement Lindsay Currie decided to share it with members who were unable to be in Baltimore for the Convergence.

The session was adapted as a webcast and offered free of charge to RAPS members. Within an hour of the email announcement, webcast registration reached the 100-participant limit. Members who were unable to register for the live webcast may listen to the pre-recorded version, which is available on-demand from the RAPS Store.

Drago used the same format for the webcast as she had during the Convergence session, except rather than voting for each proposed solution by a show of hands, they made their selections electronically via the webcast software.

The questions that were discussed include what to do when:

  • The marketing vice president, without the approval of the regulatory affairs department, submits an advertisement that violates the law.
  • The R&D department doesn’t follow the requirements for risk management.
  • The company will not provide the necessary resources for the regulatory affairs function.
  • The regulatory professional has to explain why management should comply with US Food and Drug Administration (FDA) requirements.
  • Employees need to be motivated to attend an internal training session.

As with the in-person program, the attendees agreed that the session was interesting, relevant to their work, and engaging. Comments from the attendees included:

  • “The format of the session was very nice.”
  • “I really love Webinars like these. Although this was not related to a regulatory topic, we all have to face [issues] like this every day.”
  • I learned “how to communicate the value of regulatory affairs.”

Because of the very positive response, RAPS is planning additional free webcasts for members on other topics of interest. More information will be forthcoming.

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