In just a few weeks, the PDA-FDA Joint Regulatory Conference is taking place in Washington, DC. Between 800 and 1000 attendees are expected, including good representation from FDA. I spoke with Susan Schniepp, co-chair of the meeting, vice-president of quality for OSO Biopharmaceuticals, and a member of PharmTech’s Editorial Advisory Board, to see what participants can expect this year.

During last year’s 2010 conference, FDA had just released its enforcement strategy and PDA-FDA have decided to center this year’s conference theme on Quality and Compliance in Today’s Regulatory Enforcement Environment. Clearly, the two are linked. “This year’s planning committee is hoping to educate the industry on the FDA’s enforcement strategy as well as have the attendees and FDA engage in open, honest discussions about some of the challenges facing the industry and how we, the industry, can maintain an acceptable level of compliance considering all the various contractual, marketing etc., arrangements companies are involved in with today’s global environment,” says Schniepp.

The meeting will have three tracks for participants to choose from: one on Foundations, aimed at helping attendees “get back to basics” so to speak; one on Innovation/Regulatory Science, which has been a big focus area for FDA lately (the agency issued a report in August on advancing regulatory science that targeted 8 key areas); and one on Quality and Compliance.

“As basic as it sounds, communicating effectively alleviates a lot of questions and concerns the agency might have,” said Schniepp when asked about what industry can do to improve best practices. For example, she adds, “When I think of this in terms of auditing, the CFR tells you what you need to achieve for compliance but not how you need to achieve it. It is truly a voluntary regulation and firms can design whatever system, within reason, they want to meet the regulation. What this means for the regulators is that no quality system, change control system, or complaint system they audit is the same. Whatever a company can do to communicate how their system is compliant would really help during an audit.”

Listen to a podcast of our full conversation about the upcoming meeting. We also hope attendees will stop by the PharmTech booth, number 52, during the show. See you there.