News Archive

Our branch office opens November 1, 2007

BECKER VSG - ISREAL
1 Azrieli Center
30th Floor (Round Tower)
Tel Aviv 67021
Israel

BECKER CONSULTING is pleased to sponsor:

ILSI BIOMED ISRAEL 2007
June 5-7
Tel Aviv, Israel

Bringing together the international life science and
venture capital community.
See http://www.kenes.com/biomed/conference/home.asp.

We are moving to accomodate growth.
Effective January 8, 2007, please note our new suite number:

2001 Pennsylvania Avenue NW
Suite 950
Washington, DC 20006

Welcome

We are pleased to welcome M. Blythe Karow, MBA as General Manager, Business Strategies. Ms. Karow is a recent graduate of the Darden School of Business Administration at the University of Virginia, and has an undergraduate degree in biomedical engineering. Ms. Karow's industry experience includes employment at BlueSky, Ethicon, and Medtronic.

We are pleased to announce that Robert A. Rhoades joins the firm as Practice Director, Quality Systems and Compliance. Mr. Rhoades and his team have 30 years of experience and leading technical competence in both the pharmaceutical and medical device industry. (January 2008)

We are pleased to welcome Ronda A. Balham, OD as Deputy Director, Medical Device Practice. Dr. Balham served 20 years in the U.S. Public Health Service, with senior executive positions at the FDA, including in the Office of Device Evaluation (CDRH) and the Office of the Commissioner. (September 2007)

We are pleased to welcome Laura Straub, Priyanka Vakkalanka, and Danielle Altares to our staff as Research Associates. (June - July 2007)

Invited Presentations

Phil Phillips presented at the RAPS Horizons 2007 Conference & Exhibition in San Francisco, March 28, 2007: "Device Classification Mechanisms and Regulatory Strategy." See www.raps.org.

Phil Phillips presented at the Scientific Affairs Committee Meeting of the Consumer Healthcare Products Association in Washington, DC on May 1, 2006 : "Medical Devices for Over-the-Counter Use." See www.chpa-info.org.

Dr. Ryung Suh presented in the “Ethics Forum Poster Session” at the American Public Health Association conference in Boston, MA, November 6-7, 2006. See www.apha.org.

Phil Phillips moderated the FDLI Audioconference on "An Update on CDRH’s Draft Guidance for Industry and FDA Staff – The Review and Inspection of Premarket Approval Application Manufacturing Information and Operations." September 11, 2006.

Phil Phillips participated in an audio conference entitled "Doing Double Duty: Collecting Data for FDA and CMS in the Same Study" for Compliance-Alliance LLC. June 1, 2006.

Dr. Ryung Suh and Dr. Brent R. Gibson presented in Washington, DC on May 24, 2006: "Avoiding the Pitfalls: Calculating ROI and Making the Business Case for Health Promotion and Education Programs" at the 24^th National DHPE/CDC Conference on Health Promotion and Education. See www.dhpe.org.

Kristin Zielinski directed a workshop in London, England on May 22-25, 2006: "Introduction to US FDA Regulation of Medical Devices" at IBC's 12^th Course on Medical Device Regulations.

Phil Phillips moderated "FDA Center Happenings:  Priorities and Possibilities" with Dr. Daniel Schultz, Director of the Center for Devices and Radiological Health, at FDLI’s 49^th Annual Conference on April 5-7, 2006. See www.fdli.org.

Dr. Ryung Suh presented at a pharmacoeconomics conference in Shanghai, China on March 5-7, 2006: "Economic Evaluation of Disease Management" at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 2^nd Asia-Pacific Conference. See www.ispor.org.

Brent R. Gibson and Ryung Suh presented at a prevention conference in Reno, Nevada on February 22-26, 2006: "Assessing and Improving Public Health Data" and "Toward Consensus in the Economic Evaluation of Disease Management" at the American College of Preventive Medicine annual meeting. See www.acpm.org.

Kristin Zielinski directed a workshop in Berlin, Germany on November 21-24, 2005: "Introduction to US FDA Regulation of Medical Devices" at IBC's 11^th Course on Medical Device Regulations. See www.ibc-lifesci.com. Brochure.

Ryung Suh moderated the 3^rd Annual Healthcare Day Marketing Panel for the Healthcare Business Alliance at the McDonough School of Business, Georgetown University. Washington, DC. November 18, 2005. See www.msb.edu.

Ryung Suh discussed "Humanity as a Weapon of War" at the Council on Foreign Relations 10^th Annual Term Member Conference. New York, NY. November 11, 2005. See www.cfr.org. Summary.

Phil Phillips discussed "510(k)s: Has the Bar Been Raised?" at the RAPS 2005 Annual Conference and Exhibition. Baltimore, MD. October 16-19, 2005. See www.raps.org.

Phil Phillips moderated an FDLI audioconference with FDA's Deputy Commissioner, Dr. Scott Gottlieb on October 3, 2005. See www.fdli.org.

Medical Device Manufacturers Association Workshop: What Every Medical Technology Company Should Know About the 510(k) Process. Burlington, MA. September 30, 2005. Presentation by Dr. Karen Becker: "Designing Your Study To Support a 'Substantial Equivalence' Determination". See www.medicaldevices.org.

Phil Phillips discussed "Raw Materials Specifications" at Japan's Pharmaceutical Affairs Law: What You Need to Know, sponsored by AdvaMed. Gaithersburg, MD. September 17, 2005. See www.advamed.com.

Compliance-Alliance. August 11, 2005. Teleconference with Phil Phillips: "Integrating a CMS Reimbursement Strategy into Your FDA Planning Process". See www.compliance-alliance.com.

Expert Briefings. July 27, 2005. Audioconference with Phil Phillips: "How to Meet Premarket Clearance Requirements with Evolving Device Design and Labeling." See www.expertbriefings.com.

CBI's Executive Summit on Medical Device Reimbursement and Medicare Coverage co-sponsored by The Wall Street Journal. Washington, DC. June 16-17, 2005. Presentation by Dr. Karen Becker: "Conduct a Competitive Landscaping and Analysis". See www.cbinet.com.

Fonds de Solidarite FTQ. Montreal, Canada. May 25, 2005. Presentation by Dr. Ryung Suh and Phil Phillips: "Strategic Reimbursement in the United States". See www.fondsftq.com.

A Conversation with Phil Phillips: Insights into CDRH's Office of Device Evaluation hosted by FOI Services. An interactive teleconference with Phil Phillips. May 5, 2005. See www.foiservices.com.

FDLI's Introduction to Medical Device Law and Regulation Workshop. Washington, DC. May 4-5, 2005. Presentation by Dr. Karen Becker. See www.fdli.org.

CBI's Inaugural Medical Device and Diagnostics Marketing Compliance Congress co-sponsored by The Wall Street Journal. Washington, DC. April 18-19, 2005. Presentation by Dr. Karen Becker: "Develop a Risk Management Strategy for Your DTC Advertising Campaign". See www.cbinet.com. Conference Brochure.

Women's Health: Legal, Regulatory, and Policy Issues. FDLI & National Association of Women Lawyers. Washington, DC. December 3, 2004. Dr. Karen Becker, Planning Committee. See www.fdli.org.

Medical Device Manufacturers Association Workshop: What Every Medical Technology Company Should Know About the 510(k) Process. Washington, DC. September 2004. Dr. Karen Becker on Study Designs. See www.medicaldevices.org.

FDLI's Advanced Medical Device Issues Program. San Francisco, CA. June 24-25, 2004. Dr. Karen Becker discussed "Premarketing Clinical Programs" and "Postmarketing Clinical Programs". See www.fdli.org.

Food and Drug Law Institute. Introduction to Medical Device Law and Regulation. Dr. Karen Becker. Washington, DC. October 28-29, 2002. See www.fdli.org.

Drug Information Association. Medical Devices. Successful Approaches to Approval of Class III (PMA) Products. Dr. Karen Becker. Philadelphia, PA. February 2002. See www.diahome.org.

Publications

Zielinski KM, Gardner LD, Speed RL. 2005. Postmarketing Surveillance in the US: A System under Scrutiny. Regulatory Affairs Journal (Devices) 13:67-72. Reprint (with correction).

New FDA bioresearch monitoring initiatives are summarized in Zielinski KM, Tuskey CL. 2004. FDA Bioresearch Monitoring: New Initiatives for Medical Device Clinical Trials. Regulatory Affairs Journal (Devices) 12:259-263. Reprint.

Of Interest

BECKER CONSULTING retained to provide independent quality and compliance services to heparin manufacturer in China. Reprint.

BECKER CONSULTING was a Gold Sponsor for the ILSI BIOMED ISRAEL 2007 in Tel Aviv, Israel, June 5-7, 2007. See http://www.kenes.com/biomed/conference/home.asp.

BECKER CONSULTING submitted comments to the FDA Docket on Guidance for Saline, Silicone Gel, and Alternative Breast Implants. (April 12, 2004). See www.fda.gov.

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