Get Involved! Volunteer for the New Regulatory Response Subcommittee

AAPS members can help select and respond to the regulatory policies, guidance’s, and compendia that affect the sciences in which AAPS members work. The Scientific Advisory Committee (SAC), which advises the Board of Directors on key scientific, technical, and regulatory issues, is seating a new Regulatory Response Subcommittee (RRS) to facilitate the submission of comments on regulatory documents. Deadlines will be tight, but the potential impact of this subcommittee makes it worth the effort for volunteers who care about regulatory policy.

AAPS members have always taken a strong interest in the regulations that impact the pharmaceutical sciences. This new subcommittee will build on years of collaboration with regulatory agencies through numerous workshops and submitted comments on many significant draft policies, guidance’s, and compendia.

The RRS will identify the draft policies, guidance’s, and compendia that will have significant impact on the science of AAPS members and consider whether AAPS is an appropriate respondent. Anyone, including members, AAPS Community leaders, staff, and board members, can recommend the RRS consider a draft for response.

When the RRS determines AAPS should respond to a draft, it will help the SAC seat a small team of topic-related subject matter experts to compile the response. Finalized draft responses must be reviewed by a member of the Scientific Advisory Board, and then, in accordance with the AAPS the Scientific Opinions and Comments Policy, recommended by the SAC Chair to the Board of Directors for their approval. Approved responses will be submitted to the appropriate regulatory authority as quickly as possible. Approximately a month after the closing of the response period, AAPS will make the response available to AAPS members.

In most cases, responses are due in 90 days or less, so the process to identify, assess, form a team, and generate the response must be accomplished quickly! Volunteers for this subcommittee must be ready to participate by email in quick decision-making and in drafting responses.

The RRS already has one draft guideline to consider: EMA's "Guideline on the chemistry of active substances." The subcommittee will focus on this draft as soon as it is seated.

The RRS will be composed of members nominated by interested AAPS Communities. If you are interested in participating, contact your AAPS Community’s Chair and Membership & Communities Director Maria Nadeau. Maria will confirm your membership status and your membership in the AAPS Community you wish to represent to ensure you are eligible for consideration for this role.