"We know that enforcement alone will not get us out of this problem. So our agency partners are working hard to root out fraud before it happens, and they negotiate compliance agreements in connection with their administrative remedies that establish tough structures to help prevent further instances of fraud." said Principal Deputy Assistant Attorney General Delery.

A former U.S. Customs and Border Protection (CBP) officer, his girlfriend and two of their associates pleaded guilty today in federal court for their participation in multi-year bribery and alien smuggling activities along the U.S./Mexico border.

A New Jersey company in the business of receiving the assignment of municipal tax liens pleaded guilty today for its role in a conspiracy to rig bids for the sale of tax liens auctioned by municipalities in New Jersey.

A former financial services broker was sentenced today in U.S. District Court for the Southern District of New York, for his participation in conspiracies related to bidding for contracts for the investment of municipal bond proceeds and other municipal finance contracts.

The Justice Department announced today that it will monitor the municipal special election on Jan. 8, 2013, in Branchville, S.C., to ensure compliance with the Voting Rights Act of 1965. The Voting Rights Act prohibits discrimination in the election process on the basis of race, color or membership in a minority language group.

A Massachusetts man was sentenced today to serve 45 years in prison for his participation in an international criminal network, known as Dreamboard, dedicated to the sexual abuse of children and the creation and dissemination of graphic images and videos of child sexual abuse throughout the world.

"As a result of these provisions, FIRREA is a powerful weapon for combatting financial fraud, and it will continue to play a key role in the Department's efforts to hold accountable those who violated the law," said Principal Deputy Assistant Attorney General Delery.

"Consumer advocates like NCL are the front line for so many consumers who have been defrauded and just don’t know where to turn. Like its predecessor, the Fraud Center, the new site will make it easier for consumers to report potential fraud or misrepresentation, and for law enforcement organizations, like the Civil Division, to do something about it," said Principal Deputy Assistant Attorney General Delery.

"When food or drug manufacturers lie and cut corners, they put all of us at risk. The Department of Justice will not hesitate to pursue any person whose criminal conduct risks the safety of Americans who have done nothing more than eat a peanut butter and jelly sandwich," said Principal Deputy Assistant Attorney General Delery.

"We have made protecting consumers a centerpiece of the Department’s overall anti-fraud efforts because consumer fraud affects ordinary people every day and can devastate victims," said Principal Deputy Assistant Attorney General Delery.

"The Department is engaged in efforts across the country to break down barriers to opportunity for America’s schoolchildren, and to ensure that school is a road to success, not a pipeline to prison," said Prinicpal Deputy Assistant Attorney General Samuels.

A former contract employee of the U.S. Defense Department (DoD) was sentenced today to serve 35 months in prison for his participation in a bribery and money laundering scheme arising from corruption in the award of defense contracts at Camp Arifjan, an Army base in Kuwait.

A financial investor who purchased municipal tax liens pleaded guilty today for his role in a conspiracy to rig bids for the sale of tax liens auctioned by municipalities in New Jersey.

Attorney General Eric Holder is traveling to Auckland, New Zealand, for the Fifth Annual Meeting of the Quintet of Attorneys General of the United States, the United Kingdom, Canada, Australia and New Zealand.

A Romanian national pleaded guilty today to participating in an international, multimillion-dollar scheme to remotely hack into and steal payment card data from hundreds of U.S. merchants’ computers.

Julian Zapata Espinoza, also known as “Piolin,” 32, pleaded guilty today to the murder of U.S. Immigration and Customs Enforcement (ICE) Special Agent Jaime Zapata and the attempted murder of ICE Special Agent Victor Avila in Mexico.

Liberty Reserve, a company that operated one of the world’s most widely used digital currency services, and seven of its principals and employees were charged with money laundering and operating an unlicensed money transmitting business.

A managing partner of a U.S. broker-dealer was arrested today on felony charges arising from a conspiracy to pay bribes to a senior official in Venezuela’s state economic development bank, Banco de Desarrollo Económico y Social de Venezuela (BANDES).

A federal jury today convicted four individuals for their participation in a Medicare fraud scheme involving nearly $70 million in fraudulent billings by Hollywood Pavilion (HP), a mental health care hospital.

A Los Angeles-area doctor and a patient recruiter pleaded guilty today for their roles in a power wheelchair fraud scheme that defrauded Medicare of over $10.1 million.

Three former financial services executives were sentenced today in U.S. District Court for the Southern District of New York for their participation in frauds related to bidding for contracts for the investment of municipal bond proceeds and other municipal finance contracts.

Child Cyber Safety Night at the Ballpark is the latest effort by the Justice Department and its law enforcement and community partners to encourage parents to speak with their children about online and cell phone safety and provide prevention materials. As part of the event, the Department will receive the Washington Nationals Spirit Award.

Two financial investors who purchased municipal tax liens pleaded guilty today for their roles in a conspiracy to rig bids at auctions conducted by New Jersey municipalities for the sale of those tax liens, the Department of Justice announced.

Attorney General Eric Holder today endorsed the reauthorization of the Second Chance Act, bipartisan legislation introduced by Senators Patrick Leahy and Rob Portman and its companion legislation by Representatives Danny Davis and F. James Sensenbrenner, Jr. that provides resources and support to people reintegrating into their communities after being incarcerated.

A senior official in Venezuela’s state economic development bank has pleaded guilty in New York federal court to accepting bribes from agents and employees of a New York-based broker-dealer (Broker-Dealer) in exchange for directing her bank’s security-trading business to the Broker-Dealer.

A federal grand jury in Newark, N.J., returned an indictment against six investors for their roles in a conspiracy to rig bids at auctions conducted by New Jersey municipalities for the sale of tax liens.

Three high-level executives of Tokyo-based Takata Corp. have agreed to plead guilty for their participation in a conspiracy to fix prices of seatbelts installed in cars sold in the United States.

The Tax Division of the Department of Justice today strongly encouraged Swiss banks that want to seek non-prosecution agreements to resolve past cross-border criminal tax violations to submit letters of intent by the Dec. 31, 2013 deadline required by the Program for Non-Prosecution Agreements or Non-Target Letters for Swiss Banks.

U.S. Attorney General Eric Holder on Thursday urged Congress to pass the bipartisan Smarter Sentencing Act, introduced by Senators Dick Durbin and Mike Lee.

The former president and vice president of Osaka, Japan-based Diamond Electric Mfg. Co. Ltd. have agreed to plead guilty for their participation in a global conspiracy to fix prices of ignition coils installed in cars sold in the United States and elsewhere.

A former Bank of America executive pleaded guilty today for his participation in a conspiracy and scheme to defraud related to bidding for contracts for the investment of municipal bond proceeds and other municipal finance contracts.

Today, the Justice Department announced that Andre James Hertzog, 29, was sentenced to serve 10 years in prison and eight years of supervised release for participating in a sex trafficking conspiracy. Nicole Bramer, 29, was sentenced to serve 21 months in prison, to be followed by five years of supervised release.

The heads of the antitrust agencies of the United States, Canada and Mexico – Assistant Attorney General Bill Baer of the Department of Justice’s Antitrust Division, Chairwoman Edith Ramirez of the Federal Trade Commission, Canadian Commissioner of Competition John Pecman and President Alejandra Palacios Prieto of the Mexican Federal Competition Commission – met today in Washington, D.C., to discuss their mutual efforts to ensure continued effective antitrust enforcement cooperation in our increasingly interconnected markets.

A former executive of a rubber hose manufacturer, who was extradited from Germany in early April 2014, today pleaded guilty and was sentenced to serve two years in prison for participating in a conspiracy to rig bids, fix prices and allocate market shares of marine hose sold in the United States and elsewhere.

"Each of the 2014 grant recipients are doing amazing work – day in and day out they are changing the lives of the most vulnerable residents in the District of Columbia. And they are strengthening our nation’s legal community," said Principal Deputy Director Hanson

A former New York-based tax liens company executive pleaded guilty today for his role in a conspiracy to rig bids at auctions conducted by New Jersey municipalities for the sale of tax liens.

"It’s clear that our nation will no longer tolerate sexual violence in our prisons, jails and juvenile detention centers – and that’s something we should all be proud of."

A greater Detroit-area owner of three home health agencies pleaded guilty today for his role in a $22 million home health care fraud scheme

Child Cyber Safety Night at the Ballpark is the latest effort by the Justice Department and its law enforcement and community partners to encourage parents to speak with their children about online and cell phone safety and provide prevention materials.

A true cooperator – whether a mobster or a company – must forthrightly provide all the available facts and evidence so that the most culpable individuals can be prosecuted. If a corporation wants credit for cooperation, it must engage in comprehensive and timely cooperation; lip service simply will not do. Corporations do not act criminally, but for the actions of individuals. The Criminal Division intends to prosecute those individuals, whether they’re sitting on a sales desk or in a corporate suite.

By Ashley Henderson, PhD, CATO SMS Scientist 1.0 INTRODUCTION The COVID‑19 pandemic has added an unprecedented set of challenges to the conduct of clinical trials including quarantines, travel limitations, site closures, and interruptions in the supply chain of investigational products. In acknowledgement of these challenges, the Food and Drug Administration (FDA) recognizes that protocol modifications …

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Ministers in charge of women’s economic participation in the APEC region issued a joint statement following their meeting in La Serena, Chile, on 4 October 2019.

From : Communities>>Regulatory Open Forum
Hi everyone, I just finished it, and it is a really simple task! Go ahead! Thanks Anna --------------------------------- Anna Alonzi MD Sr. Regulatory Associate Newtown PA United States ---------------------------------

From : Communities>>Regulatory Open Forum
Thank you all for participating in our Tagging Project! We're glad to hear you enjoyed it. All volunteers were entered into a drawing for a $50 Amazon gift card. See a video of the drawing attached.  I'm happy to announce that the winner is ...  @Jonathan Amaya-Hodges ! Thanks again to all who participated. If you're interested in more volunteer opportunities, see our full list here .​​ ------------------------------ Danielle Fezell Manager, Chapter & Volunteer Relations, RAPS Rockville MD United [More]

Files Attached Document
RE: Sort It Out by participating in the RAPS Tagging Project

From : Communities>>Regulatory Open Forum
Thank you RAPS, what a pleasant surprise! I appreciate the opportunity to contribute to the project! Now, if only Amazon had any toilet paper in stock... ------------------------------ Jonathan Amaya-Hodges Associate Director, Regulatory Affairs CMC Combination Products and Medical Devices Cambridge MA United States ------------------------------

Protocol trumps practice. This principle seems clear enough, but complying with it is not always as straight-forward as it sounds. Years of practicing medicine has reinforced the way a physician responds to medical situations. But do these responses run counter to the investigational plan? Can a site’s commitment to standard of care affect its ability to meet enrollment targets?


There’s a lot to consider.



What’s Your Standard of Care?
When deciding whether or not to conduct a particular study, a PI needs to verify that the protocol is aligned with practice norms. For example, an early phase trial might exclude a medication that is part of a practice’s routine therapy. Is the study placebo-controlled? Does it feature a specific comparator drug? Will it include a washout period? Any of these elements could present enrollment challenges or preclude a site from accepting a study at all. Responsible sites want to make thoughtful decisions about study suitability; they want to provide realistic enrollment estimates. Sponsors want this too, and can help sites do both these things by providing them a sufficient level of detail about protocol procedures as early as possible.


The Road to Deviations is Often Paved with Good Intentions
Therapeutic misconception – a well-documented phenomenon in clinical research – occurs when a study participant “fails to appreciate the distinction between the imperatives of clinical research and of ordinary treatment.”* Study participants are not alone in this. Researchers blur the distinction themselves when they conduct procedures that are consistent with clinical care but deviate from the protocol. This may be particularly true for PIs who recruit participants from their own practices. An endocrinologist might ordinarily reduce dosage for a particularly diminutive patient. A pulmonologist would often skip a scheduled chest x-ray she felt wasn’t needed to avoid exposing her patient to unnecessary radiation. An orthopedic surgeon may decide his patient needs more recovery time than usual before attempting her first walk. In a clinical care setting, these decisions are sound, made in an individual patient’s best interest. In a clinical trial, if they differ from the investigational plan and haven’t been approved by the Sponsor, they’re protocol deviations.**

It May be Par for the Course, But It's Still an AE
Specialists who have experience treating particular conditions are also familiar with the complications that ordinarily accompany them. A nephrologist, for instance, knows that a patient with end-stage renal disease frequently experiences bloat from a buildup of fluid between dialysis sessions. Though useful for a doctor treating patients, this knowledge can actually work against a doctor running a trial. How? A PI may fail to report a stomach ache as an AE because it’s so typical, so expected. “Bloat is common for renal patients. If I recorded every GI incident, I’d be recording AEs all day.” At its surface, this PI’s argument sounds reasonable, but what if the study drug itself is contributing to the participant’s discomfort? In order to assess the drug’s gastrointestinal effect, the PI must document the frequency and severity of all GI events.

Lab values that are either above or below normal range are also prime candidates for AE underreporting. “Of course the participant’s liver enzyme is high – we’re testing a cholesterol drug.”

The Importance of Study Oversight
Any GCP course worth its registration fee will discuss the distinction between standard of care and the study protocol. In practice, the distinction is not always as obvious as training sessions might suggest. This is where well-trained CRAs come in. As site monitors, CRAs are in a position to catch deviations that result from lapses into standard of care. Reading through progress notes, a monitor can ensure that any untoward medical event has been reported as an Adverse Event. They can verify that procedures conducted by the PI and site staff are compliant with the protocol. Then, by reviewing which types of data must be collected and emphasizing the importance of following certain protocol procedures, monitors can take the opportunity to re-educate study personnel and help them avoid these common pitfalls.

_______________________________________________________________________
* Lidz CW, Appelbaum PS (2002) The therapeutic misconception: problems and solutions. Med Care 40: V55-V63.

**Andrew Snyder of the HealthEast Care System wrote a thoughtful piece describing the compatibilities that do exist between clinical care and clinical research. His arguments provide a useful counterpoint to the issues we’re raising here. https://firstclinical.com/journal/2017/1707_Research_vs_Care.pdf

A version of this article originally appeared in InSite, the Journal of the Society for Clinical Research Sites.

WASHINGTON, D.C. – Five lawmakers introduced a bipartisan bill giving a full range of medical services to families with children who have life-limiting illnesses and who qualify for Medicaid, which currently has gaps in such coverage.

The Children’s Program of All-Inclusive Coordinated Care (ChiPACC) Act (H.R. 6560) would let states create comprehensive care programs for these children. Its authors are the Co-Chairs of the Congressional Childhood Cancer Caucus: Representatives Michael McCaul (R-TX), Jackie Speier (D-CA), G.K. Butterfield (D-NC), and Mike Kelly (R-PA), together with Representative Diana DeGette (D-CO), a senior member of the House Energy and Commerce Committee.

“Families with children facing life-limiting illnesses need all the support they can get, and they should be empowered to seek out that support,” the bill’s sponsors said in a joint statement. “We owe it to these kids and their loved ones to help ensure more compassionate care in their most trying times.”

Gaps in Medicaid coverage of hospice and palliative services have deprived many beneficiaries of the care they need because the program does not cover some of children’s unique medical needs.

Under this bill, the family of every child who qualifies for Medicaid will receive a specialized care plan covering a range of services – palliative, counseling, respite, expressive therapy and bereavement – providing them and their families greater comfort and peace of mind.

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Position
Laboratory director and independent principal investigators

Employer
Shanghai Ninth People’s Hospital affiliated to Shanghai Jiao Tong University School of Medicine

Location
639 Zhi Zao Ju Rd, Huang Pu District, 200011, Shanghai, China

Discipline
Tissue engineering and regenerative medicine related disciplines including: Stem Cell, Developmental Biology, Biomaterials, Biomedical Engineering

Aim:
Shanghai Tissue Engineering Key Laboratory is among the l…

With a generous support from the Guangzhou City Government and the Guangdong Provincial Government, Guangzhou Regenerative Medicine and Health-Guangdong Laboratory (GRMH-GDL) was launched in 2017. GRMH-GDL aims to bring together multiple leading scientific research units from Guangdong, Hong Kong, Macao and well-known international research institutes to achieve the vital goal of "Healthy China" and to cooperatively tackle the scientific and technical problems and challenges. GRMH-GDL is focused…