| Welcome
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We are pleased to welcome Maxine K. Fritz as Director, Pharmaceutical and Biologics Quality Systems and Compliance Practice. Ms. Fritz brings 23 years of experience in the field at both FDA and as a consultant to industry leaders. She is a former FDA investigator, specializing in pharmaceutical and biological product inspections, and served as the Biologics Team Leader. [Press Release]
Ms. Fritz is expanding the firm's existing pre-eminent Medical Device Quality Systems and Compliance Practice, led by Elaine Messa.
Ms. Fritz ’s Biography
Contact: maxine.fritz@becker-consult.com. |
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| Announcements
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Dr. Ron Ginor, President and Medical Director, joins the faculty this year at VIVA (Vascular InterVentional Advances) in Las Vegas, NV to be held October 20-23, 2009. Dr. Ginor will participate as part of an expert panel discussion to provide perspective on challenges facing physicians, industry, and regulatory organizations stemming from an evolving regulatory environment. [Website]
Dr. Karen Becker, Chief Executive Officer, has joined Congressional Bank's Board of Directors. "With so much turmoil at other banks, investing time and money in a bank that is stable and growing is refreshing and reassuring," commented Dr. Becker in a press release. "I was honored to join the board of such a remarkable organization."
Elaine C. Messa, Director, Quality Systems and Compliance Practice, will participate as a panelist in a discussion of current and future FDA enforcement trends as they relate to quality in the global supply chain and compliance initiatives. The session is part of the 2009 AdvaMed MedTech Conference in Washington, DC, October 12-14, 2009. [Website]
Elaine C. Messa, Director, Quality Systems and Compliance Practice, will speak at the Food and Drug Law Institute's (FDLI) Enforcement and Litigation Conference held from October 13-14, 2009 in Washington, DC. Ms. Messa, part of the planning committee and faculty, will join leading experts in the field to provide a comprehensive overview of the new regulations and policies affecting FDA-regulated industries. [Website]
Dr. Rosanne B. McTyre, Director, Biostatistics and Epidemiology, will speak on the problem of missing data in medical device trials at the 2009 FDA/Industry Statistics Workshop, held from September 23-25, 2009 in Washington, DC. The workshop features two days of invited sessions co-chaired by statisticians from industry, academia, and FDA. [Website] |
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Recruiting Dynamic Professionals
Becker Consulting is currently recruiting dynamic professionals to join our exceptional team.
Successful candidates will work daily on challenging clinical and regulatory assignments that focus on innovative products, and new business ventures in the healthcare space, with the best experts in the field.
- Project Manager, Medical Device Regulatory Affairs
- Reseach Associate
Please see the Project Manager and Research Associate position descriptions for additional information. |
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| Congratulations and Warmest Good Wishes to Phil Phillips
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After leading our medical device practice for the last 4 years, Phil is leaving Becker Consulting in mid-June.
During his time with us, Phil brought tremendous depth and insight to many client assignments, and helped our company become exceptionally well-positioned to meet the complex challenges of today’s shifting regulatory landscape.
We congratulate Phil that after almost 30 years of work in the field of FDA regulation of medical devices, he is taking steps that will allow him to devote more time to his family and his many friends and professional colleagues.
Phil intends to remain actively connected with the medical device industry. But he will no longer be responsible for managing a large consulting practice, allowing him greater time to focus on issues that are of specific interest to him.
The day to day activities of our pre-eminent medical device practice will continue to be managed by Ms. Campbell Hutton and Ms. Kristin Zielinski, both of whom have worked very closely with Phil during his tenure at Becker Consulting. Our entire medical device team coordinated carefully with Phil to ensure a smooth transition.
Phil will remain on the Scientific Advisory Board of Samson Venture Partners, the investment arm of Becker Consulting.
All of us at Becker Consulting feel privileged to have had the opportunity to work with Phil on a daily basis. We are sincerely grateful for his dedication to our company, and to each of us individually as a mentor, colleague and dear friend.
Our very, very best to Phil and his Family!
The Becker Consulting Team |
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| News
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Campbell T. Hutton, Vice President, Strategic Consulting Group, and Alice S. Bailey, Senior Consultant, interviewed Dr. Jonathan Sackner-Bernstein, Associate Director for Postmarket Operations at US FDA. The interview was published in the May/June edition of the Regulatory Affairs Journal (RAJ), Devices. [Reprint] |
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Invited
Presentations
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Elaine C. Messa, RAC, Director, Quality Systems and Compliance Practice, will chair a preconference workshop entitled "US Regulatory Essentials" for the annual Regulatory Affairs Professional Society (RAPS) meeting on September 13, 2009. This preparatory worshop, targeting individuals working towards their RAC, provides a comprehensive overview of regulations and policies affecting US regulatory affairs. Philadelphia, PA. [Website]
Phil Phillips will speak at the Medical Technology seminar: CEO roundtable on January 23, 2009 in Minneapolis, MN. He and the panel will discuss the effect the new FDA environment can have on the success of medical technology in the marketplace.
Phil Phillips, Medical Device Practice Director and former CDRH Deputy Director, will present at the Johnson & Johnson Regulatory Affairs Summit held in Newbrunswick, NJ on October 1, 2008.
Robert A. Rhoades presented at a preconference workshop entitled "US Regulatory Essentials" for the annual Regulatory Affairs Professional Society (RAPS) meeting on September 14, 2008. This preparatory worshop, targeting individuals working towards their RAC, specifically discussed compliance and enforment action. Boston, MA. Presentation.
Robert A. Rhoades and Latham & Watkins LLP taught an interactive workshop "FDA Compliance Inspections Outside the U.S." in Hamburg, Germany on June 19-20, 2008 and in Dublin, Ireland on June 24-25, 2008. Brochure. |
Phil Phillips and Kristin Zielinski discussed "Intended Use, Indications for Use and Claims; Navigating Uncharted Waters in the Device Industry" at the Advertising, Promotion and Labeling Conference hosted by the Regulatory Affairs Professional Society (RAPS), May 13, 2008, Baltimore, Maryland. Presentation. |
Phil Phillips and Ronda Balham presented "Food and Drug Law 101 and Introduction to Medical Device Law and Regulation Workshop: Understanding How FDA Regulates the Medical Device Industry " at the Center for Devices and Radiological Health (CDRH), May 12, 2008. |
Dr. Ronda Balham joined AdvaMed in China to provide training on FDA medical device regulations at the Joint Commission on Commerce and Trade, Pharmaceutical and Medical Devices Task Force, Seminar on Key Issues in Medical Device Regulation, April 9-11, 2008, Guilin, China. |
Phil Phillips discussed "How Far Can Medical Device Firms Deviate from FDA's Cleared Indications For Use?" at the Medical Device Regulatory, Reimbursement and Compliance Congress, March 27, 2008, at Harvard University. |
Kristin
Zielinski presented "Postmarket Requirements for
510(k)", "System 510(k) Requirements and Strategy" and the "FDA Process of Appeals" at Informa Life Sciences' symposium on Navigating the FDA Regulatory Framework in Amsterdam, January 24, 2008. |
| Dr. Ron Ginor discussed "Trends in Healthcare Investments - Investors' Perception of Key Success Factors - What's Hot?" at the Ernst & Young Israel Journey 2007 Conference, October 25, 2007 in Tel Aviv, Israel. |
| Tami Abudi and Micha Oestereich conducted a workshop on EU and US medical device regulation and regulatory strategy development at a meeting of the Association of Clinical Research Professionals, October 27-28, 2007 in Baltimore, Maryland. |
| Phil Phillips discussed FDA's perspective on the use of standards in premarket submissions for medical devices at the AdvaMed conference on The Use of Standards in Submissions, November 13-14, 2007 in Bethesda, Maryland. |
| Dr. Ronda Balham presented on the Premarket Approval Application process at the FDLI Introduction to Medical Device Law and Regulation, November 12-13, 2007 in Washington, DC. |
Dr. Ron Ginor, Phil Phillips, and Dr. Karen Becker presented "FDA Today: An Expert Symposium for Scientists, Venture Investors, and Corporate Executives" at ISLI BIOMED Israel 2007 on June 5, 2007 in Tel Aviv, Israel. |
| Phil Phillips conducted a workshop at the Center for Devices and Radiological Health in-house training session: "Introduction to Food and Drug Law 101 and Introduction to Medical Device Law and Regulation Workshop: Understanding How FDA Regulates the Medical Device Industry" on May 22, 2007 in Rockville, Maryland. |
Phil
Phillips moderated the session on Postmarket Surveillance with speakers Mark Heller, Susan Alpert, MD, PhD, and Donald J. St. Pierre at the Fiftieth Annual FDLI & FDA Educational Conference: "Cutting Edge Innovations: Balancing Safety and Rewards for Healthier Lives" in North Bethesda, MD, April 13, 2007. See www.fdli.org. Brochure. |
Phil
Phillips presented at the Second Annual Medical Device Regulatory, Reimbursement and Compliance Congress, on the campus of Harvard University, March 29, 2007. Brochure. |
Dr. Ron Ginor discussed "From Concept to Commercialization: The Evolution and Maturation of The Israeli Life Science Sector"
at Israel – A Pioneer in the Life Science Industry, hosted by the Government of Israel Economic Office in Houston, Haynes and
Boone LLP, and the Health Industry Council, on January 29, 2007 in Dallas, TX.
Brochure. |
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Kristin
Zielinski directed a workshop in London, England on November 6, 2006,
2006: "Introduction to US FDA Regulation of Medical Devices"
at IBC's 12th Course on Medical Device Regulations. See www.ibc-lifesci.com/meddev. Brochure. |
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Awards |
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Dr. Ryung
Suh was appointed to serve on the American Medical Association CPT Advisory Committee
through June 2010. (July 2007). |
Dr. Ryung
Suh received the Donald F. Hagen Award, from the Association
of Military Surgeons of the United States, presented for his proven commitment to
the health and safety of our nation’s fighting men and women, his actions in humanitarian
assistance and civic action projects, and in prevention and public health programs (November 2006).
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Dr. Ryung
Suh received the Jordan Fieldman
MD Award, presented by the American Medical Association for achievements
in medical and patient care issues and patient advocacy efforts (June
2006). |
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Dr. Ryung
Suh received the American Medical Association Excellence
in Medicine Leadership Award, presented in association with the
Pfizer Medical Humanities Initiative (March 2006). |
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Philip
J. Phillips received the FDA Commissioner's
Leveraging/Collaboration Award for his participation in
Counterterrorism and Emergency Preparedness activities at FDA. (June
2005). |
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Dr.
Karen M. Becker was named a finalist for the Ernst & Young
Entrepreneur of the Year® 2005 Awards in the Greater Washington
Area. (May 2005). |
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Selected Publications |
Hutton C, Bailey A . 2009.
The US FDA's Medical Device Postmarket Transformation Initiative. Regulatory Affairs Journal (Devices) 17:155-156. Reprint. |
Kent J, Meredith AL. 2008.
BK channels regulate spontaneous action potential rhythmicity in the suprachiasmatic nucleus. PLoS ONE 3(12). Reprint. Website. |
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Phillips PJ, Zielinski KM. 2008.
Claims and 510(k) Requirements: An Area of Uncertainty for Medical Devices. FDLI. Reprint. |
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Gibson BR, Suh R, Tilson HH . The U.S. Drug Safety System: Role of the Pharmaceutical Industry. Pharmacoeconomics and Drug Safety. In press. |
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Baetz JA, Tuskey CL. 2007.
Medical Device Reuse in the US. Regulatory Affairs Journal (Devices) 15:3-8. Reprint. |
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Tilson HH, Gibson BR, Suh R . 2006.
FDA and the Drug Safety System: The Role of the Pharmaceutical Industry. Commissioned by the Institute of Medicine Committee on the Assessment of the U.S. Drug Safety System. |
Becker K, Whyte J. (eds.). 2005. Clinical Evaluation of Medical Devices. Principles and Case Studies, 2nd Ed. Towata, NJ: Humana Press. See www.humanapress.com. |
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Phillips
PJ, Lynne JC. 2005.
Unnecessary 510(k) Fillings: A Waste of Industry and FDA Resources. Regulatory Affairs Journal (Devices) 13:341-345. Reprint. |
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Zielinski
KM, Payne KH. 2004. The De Novo 510(k) Process - How to
Down-Classify Novel Devices Automatically Placed in Class III. Regulatory Affairs Journal (Devices) 12:73-78. Reprint. |
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Becker
KM, Flannery EJ, Henteleff TO. 2003.
Scientific Dispute Resolution: First Use of Provision 404 of the Food
and Drug Administration Modernization Act of 1997. Food and Drug Law Journal
58:211-222. Reprint.
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Becker
KM. 2002. A Primer on Medical Device Regulation in the
U.S. Part II of II. Premarket Approval Applications (PMAs). Regulatory Affairs Journal
(Devices) 10:103-109. Reprint. |
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Press |
Comments submitted to FDA by Phil Phillips, Medical Device Practice Director and former CDRH Deputy Director, for a guidance on 510(k) submissions of devices or combination products with antimicrobial agents were reported by The Gray Sheet, September 1, 2008. See www.thegraysheet.com. Comments.
Comments by Phil Phillips defending FDA while it faces new challenges were published in The Regulatory Affairs Journal, Jan/Feb 2008. Reprint. |
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Comments
by Phil Phillips on the challenges FDA continues to face were
published by Medical Device & Diagnostics Industry Magazine,
May 2006. See www.devicelink.com/mddi.
Reprint. |
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Remarks
by Phil Phillips on the controversial CDRH approval of Cyberonics neurostimulation
device were reported by The Gray Sheet, February 27, 2006.
See www.thegraysheet.com.
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Q&A
with Phil Phillips on "The Modernization of ODE."
Medical Device & Diagnostics Industry Magazine. August 2005. See www.devicelink.com/mddi.
Reprint. |
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Remarks
by Dr. Karen Becker on FDA mandated post-approval studies were
reported by The Gray Sheet, February 23, 2004. See www.thegraysheet.com.
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Of
Interest |
| BECKER CONSULTING satellite offices located at: 67 Park Place
East, Morristown, NJ 07960 and 440 Ninth Avenue, 16th Floor, New York, NY 10001. |
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