Brian Malkinbrian
Senior Counsel
McGuireWoods LLP


Mr. Malkin’s practice areas include food and drug law, as well as litigation and strategy related to patent validity and infringement and, in particular, the confluence of food and drug law and patent law. Mr. Malkin’s experience uniquely bridges more than 21 years of food and drug law practice with over 11 years of intellectual property law practice.


Brian will be one of the distinguished presenters at the 6th Annual Medical Device Regulatory Affairs: Securing Clearance & Maintaining Compliance Conference.


Why is the 6th Annual Medical Device Regulatory Affairs: Securing Clearance & Maintaining Compliance Conference important to regulatory affairs executives?
Q1’s Annual Medical Device Regulatory Affairs Conference provides one place to learn about medical device regulatory happenings in the U.S. and abroad.


How has Regulatory Affairs evolved in the last several years?
Regulatory Affairs professionals are now expected to know not only their home jurisdiction but also to help plan strategies for world-wide development, along with product life cycle considerations. In addition, new programs at FDA’s CDRH have swung the tide to consider product development in the U.S. first.


What initiatives are on the horizon at your organization in 2016?
We are looking for new ways to get to the market faster with expedited approvals or to obtain product funding faster with early feasibility studies. We are also looking for creative solutions to bring new products to the market without the need for a full premarket approval.


Why is this conference important to you as an industry leader?
It is important to stay on top of new trends and to share ideas from previous product development experiences.


If you had to describe Regulatory Affairs in one word, what would it be?
Regulatory life cycle management for new and developed products with an eye to the future.


What topics are you most excited about for the conference program this year?
I am looking forward to hearing from my colleagues overseas to gain greater insight into global product strategies.


What are the “key takeaways” for your presentation/panel discussion?
Companies should consider FDA’s Early Access Pathway toward the beginning of product development when De Novo or Premarket Approval Application are the only options for certain products with unmet needs for life-threatening conditions and diseases.


Are there any blogs, forums, industry associations that you follow in relation to Regulatory Affairs?
AdvaMed Smartbrief, Gray Sheet.