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Regulatory Roundup

Wednesday, November 15, 2023 (8:00 AM - 4:00 PM) (EST)

Description

Join us for our Regulatory Roundup, designed to give RA, QA and C-level executives updates on the global and domestic regulatory issues facing the industry.

Get exclusive early bird pricing until 9.29!

We will provide a Uniform Certificate of Attendance should you wish to apply for continuing education units (CEU).

AGENDA

The agenda will run from 8:00 AM - 4:00 PM and includes FDA and global regulatory updates, trends in FDA approvals, sessions focusing on AI, cybersecurity and new technologies, fireside chats with industry leaders, and a keynote and Q&A with the FDA.

SPEAKERS

	Troy Tazbaz Director of Digital Health Center of Excellence (DHCoE) Center for Devices and Radiological Health (CDRH) FDA Troy Tazbaz is Director of Digital Health Center of Excellence (DHCoE) at FDA. DHCoE within the Center for Devices and Radiological Health (CDRH) is responsible for envisioning a future of safe and effective healthcare delivery with a focus on advancing public health goals with the use of technology. Troy Tazbaz is responsible for providing leadership in technology evaluation and integration into clinical care, policy development to establish digital health guidelines, and strategic public-private institution partnerships. Prior to joining FDA, Mr. Tazbaz was at Oracle for 11 years, holding a variety of technical and business responsibilities in building and scaling the cloud business as Senior Vice President of Industry Business Unit Strategy & Operations.
	Rajesh Misra Principal KPMG Rajesh is a principal with KPMG and leads the Life Sciences Quality and Regulatory practice in the US. He works with the Life Sciences organizations in solving their most pressing quality, regulatory and operational challenges across the entire value chain. Rajesh advises organizations in current good manufacturing practices (“cGMPs”) and quality systems, regulatory pathways, commercialization, and post-market surveillance. He is passionate about leveraging emerging and disruptive technologies to address Quality and Regulatory challenges within the Life Sciences industry.
	Amra Racic, MBA Senior Director, Government Strategy, MedTech Veeva Systems As Senior Director of Government Affairs, MedTech at Veeva Systems, Amra is responsible for understanding the challenges and opportunities of medtech companies as well as representing the company in major industry associations to help foster industry progression. She has more than 23 years of experience in the healthcare industry, most of which were in large medical device companies in a variety of regulatory roles. Most recently, Amra led regulatory intelligence activities for Abbott’s Medical Device Division where her team was responsible for receiving, analyzing, and interpreting regulations that had the potential of impacting Abbott or wider industry. Prior to Abbott, Amra held leadership roles across regulatory, clinical, and quality at Bayer and Medtronic. She has also represented the medical device industry in various association working groups include Advamed, RAPS, WHO, IMDRF, and the FDA.
	Nicholas Abbondante Chief EMC Engineer Intertek Nicholas has served as Intertek’s Chief EMC Engineer since 2013, responsible for technical support of Intertek’s global network of 24 EMC labs. In his 22+ years with the company, he has been involved in testing a wide range of radio and electronic equipment to EMC requirements for regulatory domains around the world, specializing in transmitters and medical devices. He is the Technical Manager of Intertek’s TCB program and is TCB Council Board Vice Chair, and serves as the CISPR/A Secretariat. An active participant in many ANSC C63 standards projects, he is chair of both C63.31 for ISM device measurement and C63.25.3 for 18-40 GHz test site validation, and was recently elected as the incoming chair of Subcommittee 4 for wireless and ISM equipment measurements. He is also a working group member of C63.10 and C63.26 for radio testing, C63.4 Emissions, C63.16 ESD, C63.33 EAS immunity and the recently completed C63.2 Receiver, C63.29 Lighting and C63.30 Wireless Power Transfer standards. Nick has a Bachelor’s degree in physics from the Worcester Polytechnic Institute (WPI) in Massachusetts, USA.
	Frederick (Rick) R. Ball Partner Duane Morris Frederick focuses his practice on assisting companies or individuals when they are adverse to state or federal governments, including administrative, civil and criminal matters, with the FDA, FTC, DEA, CMS, OIG and other federal and state regulatory agencies. He serves as a team lead for the Duane Morris Life Sciences and Medical Technologies industry group. Mr. Ball helps pharmaceutical companies, biologics manufacturers, medical device manufacturers, contract service providers, food companies (including supplement manufacturers), pharmacies, long term care providers, and other health care providers navigate the complex challenges faced by state and federal regulation of their industries including complying with current Good Manufacturing Practices, price reporting (AMP, AWP, ASP, etc.), the Foreign Corrupt Practices Act, False Claims Act, and Anti-Kickback Statute, as well as meeting labeling and advertising requirements. Mr. Ball assists companies bring product to market through patent analysis, identifying marketing and approval pathways, and, when necessary litigation. Mr. Ball is experienced in conducting internal investigations and advising companies on actions following the investigation. Mr. Ball emphasizes a team approach to client problem solving and manages matters to achieve client goals both financial and legal.
	Mercè Guerra Regulatory Affairs Manager Alira Health Mercè Guerra is Alira Health’s Regulatory Affairs Manager, leading the development and regulatory activities for Medical Devices (MD) and In Vitro Diagnostics (IVDs) in the EU and U.S., and contributing to product strategy for securing CE marks and FDA clearance. Her expertise is in MD/IVD strategy and regulatory activities, including CE marks, CER, pre-RFD, 510(k), PreSubs, BDD, 513 (g), and De Novo requests. Prior to joining Alira Health in 2021, Mercè worked in MD and IVD regulatory affairs as part of Drug Development and Regulation S.L. (DDR, now Veristat). She has also worked in drug development for a range of indications and on EMA-related activities like scientific advice, orphan drug designation and briefing meetings. She has a bachelor’s degree in Human Biology and a master’s degree in Pharmaceutical and Biotechnology Industry, both from the Universitat Pompeu Fabra (UPF).
	Coleen Hill Attorney Duane Morris Coleen Hill is a trial attorney representing clients in the life sciences industry in complex commercial disputes. She holds a leadership role in Duane Morris’ Life Sciences and Medical Technologies Industry Group. In addition, she helps pharmaceutical companies, biologics manufacturers, medical device manufacturers and pharmacies navigate the complex challenges faced by state and federal regulation for their industries.
	Benny Lam, PhD Director of Regulatory Software Strategy Philips Benny Lam is Director of Regulatory Software Strategy in Philips’ Innovation & Strategy organization overseeing a number of complex regulatory strategy and submission projects. He is leading several initiatives on AI-enabled medical device and software platform regulatory framework development with the objective to improve end-to-end operational excellence of Philips’ regulatory organization and its stakeholders for commercial success. Prior to joining Philips, Benny was with US FDA Center for Devices and Radiological Health (CDRH), firstly as a Lead Reviewer in Division of Radiological Health (now OHT8), then Digital Health Policy Staff, leading numerous pre-market and post-market submission reviews as well as development of regulations, guidance documents, and policies.
	George Strom Business Development Director of IOT Intertek George has worked with medical device manufacturers around the world to help them meet all of their assurance, testing, inspection, and certification needs. George’s 20+ years in the Quality Assurance & Safety arena bring insight into the unique challenges of launching a product in today’s Connected World. Prior to Intertek, George worked in Sales and Marketing within the Computer & Office Automation Industry. He is a proud alumnus of U-Mass Lowell and lives in the Greater Boston Area.