Patrick Lee is currently a Regulatory Affairs Consultant for the Anson Group. Patrick is involved in providing regulatory and compliance service to companies and in obtaining Worldwide regulatory approvals. He was formerly the Senior Director of Regulatory Affairs, Emerging Market, at Solta Medical. Prior to Solta, Patrick was the Manager of Regulatory Affairs at Micrus Endovascular (a Johnson & Johnson Company). Patrick has broad experience in the development of many types and classes of medical devices including implants, non-invasive devices, electronic and electrical equipment, and drug-delivery devices. Patrick’s involvement in FDA-regulated industries includes health-care, medical device, and nutritional products. Patrick received his Chemical Engineering BS from Cornell, MS in engineering from Columbia, and MBA from the Anderson School at UCLA. He is a licensed Professional Engineer in the states of New Jersey and California and holds several patents. Patrick holds the Regulatory Affairs RAC (US) designation.
The presentation will focus on why medical device companies should devote sufficient resources to develop a robust global regulatory strategy. Most industry insiders will recognize the importance and challenges to obtain regulatory clearances but often slip in terms of supporting useful activities until it is late in the game. Very often, the focus is on one region alone: typically a US approval or a European CE Mark. When in-fact, a carefully chosen regulatory strategy will serve to bring the company into appropriate compliance early and apply itself into obtaining additional regulatory approvals in a logical and systematic manner.
We will discuss the “how” and “what” in obtaining regulatory approval – the challenges posed by regulatory authorities. We will examine the similarities and differences between the different regions. We find that while differences are there, most countries share similar requirements for Quality compliance and Regulatory Approvals. The good news is that these requirements are increasingly being harmonized. The not so good news is that harmonization isn’t happening fast enough and there are still inconsistencies.
Most importantly, we will discuss the internal difficulties of regulatory affairs. In many companies the challenges come from within – in the form of non-commitment, lack of support, and often competing interests. The important issue regarding regulatory affairs is that it really is an important business function that impact profit and loss directly. It, along with Quality Assurance, is not a back-office function. Regulatory affairs should be treated as serious business in businesses. The presenter will share his insights gained from working with and observing many medical device companies in this endeavor.