NSF Becker & Associates Consulting Inc. Launches New 360 Corporate Compliance Program for the Life Sciences Industry

NSF Becker & Associates Consulting, Inc., part of  global independent public health organization NSF International, has launched a new program to assist companies in achieving 360 operational compliance to the commercial practices of the life science industry.  Industry veteran Francisco (Frank) T. Rivas, who has more than 25 years’ experience in all aspects of the pharmaceutical, diagnostics and medical device industry, has been appointed to lead the NSF Becker Corporate Compliance Practice Group.

Press Release

NSF International Announces Acquisition of Becker & Associates Consulting, Inc.

NSF International has announced the acquisition of Becker & Associates Consulting, Inc.

NSF International, founded in 1944, originally as an offshoot of the University of Michigan School of Public Health, is today an independent, global public health and safety organization which develops product standards as well as tests and certifies products for food, water, health, and consumer products.

The integration of Becker & Associates Consulting, Inc. and NSF International offers NSF a broader scope of services and wider experience in the areas of pharmaceutical and medical device regulation, and global quality systems.

Please find a full press release below, as well as the ad which will run in major papers in the coming days.

Press Release

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SteadyMed CEO Featured on NBC for Charity Work

Becker & Associates Consulting sponsored Ironman triathlete Jonathan Rigby was recently interviewed in an NBC report highlighting his charity work and foundation, Tri For Kids, which raises money to purchase insulin pumps for underprivileged diabetic children.  Jonathan has Type 1 Diabetes, and began competing in triathlons in order to combat some of the symptoms of his life-threatening condition.  He has competed in over 100 races, including 10 Ironman races, and regularly speaks to young children with diabetes to inspire them to overcome this debilitating disease.

Jonathan serves as CEO of SteadyMed Therapeutics, a start-up healthcare company with headquarters in San Francisco and research and development offices in Israel.  

Seminal Article in PharmExec on the Impact of GSK Settlement

Pharmaceutical Executive Magazine has published an in-depth article on the corporate integrity agreement (CIA) signed by GlaxoSmithKline (GSK) following a $3B settlement with the United States Department of Justice.  The settlement was the result of allegations of “off-label marketing practices in support of Paxil and Wellbutrin,” in addition to allegedly hiding safety data related to Avandia and falsifying price reporting practices.  The article also highlights GSK’s implementation of extensive systems to reform industry best practices as a result of the CIA.

Dr. Ron Ginor, CEO of Becker & Associates Consulting, is quoted in the article regarding the impact of this settlement and the role of internal compliance programs and policies in preventing crippling enforcement actions before they escalate.  Becker Consulting, in partnership with NSF International and NSF-DBA, is developing an industry-leading team focused on meeting the rapidly evolving compliance needs of the life sciences industry.  For more commentary from Dr. Ginor and to read the full article in Pharmaceutical Executive Magazine, please see the link below.

Compliance Kulture:  The Facts Behind GSK’s CIA

Becker Daily Dose - February 11, 2013

Today, FDA announced the availability of a draft guidance document entitled, “Distinguishing Medical Device Recalls From Product Enhancements; Reporting Requirements.”  This draft guidance intends to clarify when a potential change to a device is a recall, distinguish between those changes and product enhancements, and to identify the reporting requirements for both recalls and product enhancements.
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Follow NSF International

In order to learn more about NSF International, and follow recent updates about the company's services to protect human health and the environment, use the links below to connect to NSF International on Facebook and Twitter.

NSF International on Facebook

NSF International on Twitter

NSF Health Sciences on Twitter

SteadyMed CEO Completes IronMan UK

Becker & Associates Consulting, Inc. is proud to announce Jonathan Rigby’s successful completion of the IronMan UK.  Becker Consulting sponsored Mr. Rigby’s efforts in the 2.4 mile swim, 112 mile bike, and 26.2 mile run competition.  Mr. Rigby, CEO of SteadyMed Therapeutics, competed in the race while managing his Type 1 diabetes with the goal to both raise funds for diabetes research and to serve as inspiration for younger individuals with diabetes.  He will be returning to the United States to use the funds raised to donate insulin pumps to underprivileged children in need of help managing the condition.

To read Mr. Rigby’s personal report of the race, please follow the link here.

Food and Drug Law Journal - Your Business in Court and at Federal Agencies

The Food and Drug Law Journal (June 2012) published its annual article, “Your Business in Court and at Federal Agencies: 2010-2011,” that examines agency behavior, court decisions and legislative developments that affect FDA-regulated businesses.  The authors found that enforcement data demonstrates that the “government continues to aggressively pursue Manufactures…”  and noted that FDA is “undertaking initiatives with foreign agencies and stationing larger number of FDA employees in foreign countries.”  The article concludes with the recommendation that “Companies must evaluate their internal compliance mechanisms and make sure they are positioning themselves to handle the new enforcement environment.”

For more information:
Preview of Article
FDLI

SteadyMed CEO to Compete in Ironman UK

BECKER & ASSOCIATES CONSULTING, INC. is proud to announce the sponsorship of Jonathan Rigby in the July 22nd Ironman UK, a triathlon consisting of a 2.4 mile swim, 112 mile bike, and 26.2 mile run.  Jonathan serves as CEO of SteadyMed Therapeutics, a start-up healthcare company with headquarters in San Francisco and research and development offices in Israel.  Samson Venture Partners is an investor with SteadyMed Therapeutics.

Jonathan has Type 1 Diabetes, and began competing in triathlons in order to combat some of the symptoms of his life-threatening condition.  He has competed in over 100 races, including 10 Ironman races, and regularly speaks to young children with diabetes to inspire them to overcome this debilitating disease.

Jonathan will be running the Ironman UK to also raise awareness for the fight against cancer, a disease diagnosed in both of his parents.  Please join BECKER CONSULTING as we wish Jonathan the best of luck in his courageous fight.

FDA Pathway to Global Product Safety and Quality

Following recent enforcement actions taken by FDA against global pharmaceutical and medical device companies, renewed interest has been generated towards a report published by FDA entitled “Pathway to Global Product Safety and Quality.”  In the report, FDA states that the rise in number of imported drugs and devices has led the Agency to expand “its capabilities and regulatory authority.”  Additionally, FDA has opened additional offices in key international locations and materially increased the number of certain types of foreign inspections.

As a service to our colleagues, please find the Special Report linked here.

Becker & Associates at FDLI's "The Intersection Worlds of Drug, Device, Biologics, and Health Law"

Please join BECKER CONSULTING at the Food and Drug Law Institute’s conference on “The Intersecting Worlds of Drug, Device, Biologics, and Health Law” next week at the St. Regis hotel in Washington, DC.  The conference, co-sponsored by the American Health Lawyers Association, will take place on Monday and Tuesday, May 21-22, and will address three significant areas of intersection in FDA and Health Law:  reimbursement, fraud and abuse, and research/clinical trial issues.  More information and registration are available here:  
http://www.fdli.org/conferences/conference-pages/the-intersecting-worlds-of-drug-device-biologics-and-health-law.

Staff News

Elaine Messa, Executive Vice President, Medical Device Practice, Becker Consulting, will be co-chairing the Ninth Annual Medical Device Quality Congress, May 16-18, 2012.  The Congress includes presentations by both current FDA officials as well as industry leaders, and will focus on the five areas where FDA targets its enforcement.  

Congress Website

Becker Consulting - FDLI Diamond Sponsor

BECKER CONSULTING is pleased to be a Diamond Sponsor at The Food and Drug Law Institute (FDLI) Annual Conference, being held April 24-25, 2012 at the Ronald Reagan Building/International Trade Center in Washington, DC.  We look forward to seeing all of our Daily Dose readers who will be attending the conference at our booth in the exhibit hall.     

Becker & Associates Consulting, Inc. Welcomes Six Leading Experts

Becker & Associates Consulting, Inc. is proud to announce the newest members and affiliates of the BECKER CONSULTING team:  

•         Mary Getz, PhD – Director of Quality Systems, Medical Device Practice
•         Larry Schum – Principal Consultant
•         Carrie Neuberger – Director of European Strategies
•         Merry Lee Bain – Regulatory Expert

We are also excited to welcome two members of our Expert Advisory Committee as full expert consultants on the Becker team:

•         Tim Ulatowski – Compliance Expert; Regulatory Expert
•         Wally Pellerite – Compliance Expert

Staff News

Ron Ginor, MD, Chief Executive Officer of BECKER CONSULTING, will be presenting at the first Seminar on Innovation and Invention in the Neurosciences at the American Association of Neurological Surgeons (AANS) Annual Meeting on Sunday, April 15, in Miami, FL.  Dr. Ginor will speak at 10:45AM ET about the role of the regulatory pathway and building value for innovative products.  

AANS Annual Meeting

Staff News

Andy Papas, PhD, Director of Regulatory Affairs for the Pharmaceuticals and Biologics Practice at BECKER CONSULTING, and Daniel Kracov, Partner and Head of the FDA and Healthcare Regulatory Practice Group at Arnold & Porter LLP, will be leading a webinar for BioWorld entitled, “Critical Industry Update:  Biosimilar Product Development.”  Dr. Papas and Mr. Kracov will address key developments in the regulatory landscape for biosimilar products, specifically discussing important topics contained in recently released FDA guidance documents related to biosimilars, as well as considering other important issues for the biotechnology industry. This interactive webinar will be held next Wednesday, April 18, 2012 from 2-3:30 PM ET, and details on how to join the conference can be found here.  

BioWorld Webinar

Join Our Team

Becker & Associates, Inc. is looking for skilled compliance and regulatory experts to join our team on a contract basis.  Do  you have FDA and/or industry experience with medical device, pharmaceutical, or biologics regulation and compliance?  Please use the link below to learn more and to contact us regarding the positions available.  We look forward to hearing from you

Contract-Based Employment at Becker & Associates, Inc.

Grand Rounds with Tim Ulatowski

Tim Ulatowski, former Director of the Office of Compliance at FDA's Center for Devices and Radiological Health, spoke at Becker Consulting this afternoon regarding his background and experiences at FDA over his 36 year career with the agency.   Included was a discussion of the interactions between the Offices of Device Evaluation and Compliance, current FDA trends, initiatives, and enforcement actions.  Mr. Ulatowski now serves as a Director on the Becker Consulting Expert Advisory Committee.

Becker 2012 Team Kickoff

Looking forward to working together with you to make 2012 a productive and successful year.

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Staff News

Harold "Wally" Pellerite, Director of the Medical Device Compliance Committee at Becker Consulting, will speak on a panel during the “Enforcement, Litigation and Compliance Conference” held by the Food and Drug Law Institute (FDLI) on December 6-7, 2011, at the Westin Georgetown in Washington, DC.   Mr. Pellerite will be discussing quality and recall issues during the December 6 afternoon panel on “Medical Product Safety.”

Conference Information

Staff News

Ron Ginor, MD, Chief Executive Officer of Becker Consulting, spoke on a panel during the “Issues in Global Health: Advancing Efficiency and Quality through Regulatory Science” symposium sponsored by the Johns Hopkins Carey Business School and the Food and Drug Law Institute (FDLI) on December 2, 2011, at the National Press Club in Washington, DC.   Dr. Ginor used case studies and recent examples to speak to the regulatory realities facing manufacturers and affecting public health officials during the second morning panel on “Realities of Global Compliance.”  

JHU News Release
Symposium Information

Press Release

Becker & Associates Consulting, Inc. (Becker Consulting) is proud to announce the addition of Tim Ulatowski, former Director of the Office of Compliance within the Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA), as Director, Medical Devices on the Becker Consulting Expert Advisory Committee.  Mr. Ulatowski has over 36 years of public health experience, including more than 25 years in multiple leadership positions at FDA’s CDRH.  

Press Release

Did you know?

Of the Fortune 500, Becker Consulting serves:  

• 5 of 6 in Medical Products & Equipment;
• 8 of 12 in Pharmaceuticals;  
• 3 of 4 in Scientific Equipment; and
• 4 of 6 in Household and Personal Products   

We also serve the #1 in each sector.




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The Becker™ Daily Dose™ keeps readers informed with the latest FDA regulatory and compliance news, important policy and legislation updates, and coverage of upcoming panels and meetings.  





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