The Department of Justice today announced that it is requiring US Airways Group Inc. and American Airlines’ parent corporation, AMR Corp. to divest slots and gates at key constrained airports across the country to low cost carrier airlines (LCCs) in order to enhance system-wide competition in the airline industry resulting in more choices and more competitive airfares for consumers.

The city of Shreveport, La., has agreed to make significant upgrades to reduce overflows from its sanitary sewer system and pay a $650,000 civil penalty to resolve Clean Water Act (CWA) violations stemming from illegal discharges of raw sewage, the Department of Justice and the U.S. Environmental Protection Agency (EPA) announced today. The state of Louisiana, a co-plaintiff in this case, will receive half of the civil penalty.

The Department of Justice today announced it is proposing a regulation that will clarify who, due to mental health reasons, is prohibited under federal law from receiving, possessing, shipping or transporting firearms. In addition to providing general guidance on the federal law, this clarification will help states determine what information may be appropriately shared with the federal background check system for firearms transfers – the National Instant Criminal Background Check System (NICS) – in order to keep guns out of the hands of individuals who may be a danger to themselves or others.

A Dallas-based group of companies and their owner must either stop importing vehicles or follow a comprehensive compliance plan to settle Clean Air Act (CAA) violations stemming from the alleged illegal import of over 24,167 highway motorcycles and recreational vehicles into the United States without proper documentation.

More than 30 tribal leaders, juvenile court judges, child advocates, juvenile justice system experts and community members from the Salt River Pima-Maricopa Indian Community testified today in the second public hearing of the Advisory Committee of the Attorney General’s Task Force on American Indian and Alaska Native Children Exposed to Violence.

Alpha Natural Resources, Inc. (Alpha), one of the nation’s largest coal companies, Alpha Appalachian Holdings (formerly Massey Energy), and 66 subsidiaries have agreed to spend an estimated $200 million to install and operate wastewater treatment systems and to implement comprehensive, system-wide upgrades to reduce discharges of pollution from coal mines in Kentucky, Pennsylvania, Tennessee, Virginia and West Virginia.

Halifax Hospital Medical Center and Halifax Staffing Inc. (Halifax), a hospital system based in the Daytona Beach, Fla., area, have agreed to pay $85 million to resolve allegations that they violated the False Claims Act by submitting claims to the Medicare program that violated the Physician Self-Referral Law, commonly known as the Stark Law.

Noting that African-American and Hispanic males are arrested at disproportionately high rates, U.S. Attorney General Eric Holder said Monday that the Justice Department will seek to collect data about stops, searches and arrests as part of a larger effort to analyze and reduce the possible effect of bias within the criminal justice system.

Baptist Health System Inc. (Baptist Health), the parent company for a network of affiliated hospitals and medical providers in the Jacksonville, Florida, area, has agreed to pay $2.5 million to settle allegations that its subsidiaries violated the False Claims Act by submitting claims to federal health care programs for medically unnecessary services and drugs.

The Justice Department filed a joint motion today for entry of a landmark consent decree to resolve allegations that the Law School Admission Council engaged in widespread and systemic discrimination in violation of the Americans with Disabilities Act.

The president and chief executive officer of Virginia-based Symplicity Corporation pleaded guilty today to conspiring to hack into the computer systems of two competitors to improve his company’s software development and sales strategy.

The Justice Department today released its latest compliance assessment of mental health services at the Los Angeles County Jails based on a memorandum of agreement designed to protect the constitutional rights of prisoners with serious mental illness at the jails.

The Justice Department reached an agreement today with Commercial Cleaning Systems, a janitorial services company with headquarters in Denver. The agreement resolves claims that the company discriminated against work-authorized non-U.S. citizens in violation of the Immigration and Nationality Act (INA)

And equally important, I want to thank all of you -- the gathered Ministers, Deputy Ministers, Attorneys General, Supreme Court Justices, and criminal legal aid providers and experts -- for participating in this conference. Your presence here epitomizes the dual truths that all free people, wherever they may live, lay valid claim to equality in the eyes of the law, and that the majesty of the law finds its best and highest use in the service of justice.

Ahmed Abu Khatallah, aka Ahmed Mukatallah, made his first appearance today in the U.S. District Court for the District of Columbia on a federal terrorism offense arising from his alleged participation in the Sept. 11 through 12, 2012, terrorist attacks in Benghazi, Libya, which resulted in the deaths of Ambassador J. Christopher Stevens, Sean Smith, Tyrone Woods and Glen Doherty

The Departments of Justice and Education announced today that they have reached a comprehensive agreement with the Jefferson Parish Public School System in Louisiana (JPPSS) to ensure that all students can enroll in school regardless of their own national origin or immigration status, or that of their parents or guardians. The agreement also resolves complaints regarding JPPSS’ policies and practices for communicating with parents who have limited English proficiency (LEP) and JPPSS’ response to alleged harassment of Latino students based on their national origin

Mobile, Alabama-based Infirmary Health System Inc. (IHS), two IHS-affiliated clinics and Diagnostic Physicians Group P.C. (DPG) have agreed to pay the United States $24.5 million to resolve a lawsuit alleging that they violated the False Claims Act by paying or receiving financial inducements in connection with claims to the Medicare program, the Justice Department announced today

The Justice Department announced today that Community Health Systems Inc. (CHS), the nation’s largest operator of acute care hospitals, has agreed to pay $98.15 million to resolve multiple lawsuits alleging that the company knowingly billed government health care programs for inpatient services that should have been billed as outpatient or observation services. The settlement also resolves allegations that one of the company’s affiliated hospitals, Laredo Medical Center (LMC), improperly billed the Medicare program for certain inpatient procedures and for services rendered to patients referred in violation of the Physician Self-Referral Law, commonly known as the Stark Law. CHS is based in Franklin, Tennessee, and has 206 affiliated hospitals in 29 states

This blog was written by Ankit Mahadevia, CEO of Spero Therapeutics, as part of the From The Trenches feature of LifeSciVC.  If CEOs have empowered their teams effectively, they have three roles during times of rapid change: Motivator in chief

The post The Balancing Act: Taking A Systematic Approach To Hard Decisions In Times Of Rapid Change appeared first on LifeSciVC.

From : Communities>>Regulatory Open Forum
Hi All, Always appreciate and respect the great advice that comes through this forum: The scope of my question is CE Mark of a Class IIa medical device system under the MDD (and then eventually MDR): We have Class I devices which will be CE Marked through self-certification. These devices can be used with other CE marked products (not owned by us). One of which is not CE Marked as a medical device (conformity to machinery and low voltage directives). In terms of what we consider this vendor, what [More]

Q: Do study site personnel need to be able to answer questions about sponsor-provided computer systems during an inspection?

A: Yes, and there’s a simple thing that sponsors and CROs can do to prepare their sites.

This excerpt was lifted from an online, interactive course entitled “Developing a Part 11 Compliance Plan in Clinical Research.” While the course mainly targeted sponsors and CROs, who have the heaviest regulatory burden in this area, sites also have Part 11 and validation concerns, as demonstrated by this question.

Presenter Lisa Olson, a CSV/Part 11 expert with Polaris Compliance Consultants, briefly described her recommendation, which is both simple and effective. (And since that is total catnip to a compliance blogger, I interviewed her after her presentation to develop the following piece.)

So here it is. Here’s what she said...

Clinical research sites rely heavily on technology to store and manage study data, so regulators are focusing on computer systems and electronic data more than ever before. Many of the systems – such as Electronic Data Collection (EDCs), Interactive Response Technology (IRTs), and e-diaries – are selected and largely controlled by sponsors, CROs, and/or third-party vendors. That doesn’t mean, however, that site staff won’t be expected to answer questions about these systems during a regulatory inspection. Quite the contrary: site personnel are responsible for the integrity of the data these systems house. They need to be able to demonstrate the knowledge required to meet their regulatory obligations.

No one is expecting site staff to be computer specialists; the expertise on these systems resides within the sponsor/CRO/vendor organizations. But the better a site can satisfy a basic, frontline inquiry into the systems it uses, the less likely it is that an inspector will pursue additional lines of questions.

So how can sponsors and CROs help?

They can provide a set of short summaries (one page per system) that answer the questions regulators are likely to ask site staff members. Filed in the Investigator Site File (ISF), ready for use, these summaries will be valuable resources.


The Basics

First, sponsors/CROs should supply identifying information: the name of the system, the vendor, the version of the system currently being used, and a few sentences that describe what the system does.
User Access and Control

To ensure both data integrity and compliance with Part 11 e-record/e-signature regulation, it’s essential that access to a system be controlled and data entry/updates be traceable to a specific person. To that end, the one-pager should describe how unique logins are assigned and how users are restricted to activities appropriate to their roles in the study. A monitor requires read-only access to an EDC system. A study coordinator needs to be able to enter and change EDC data. A Principal Investigator must be able to sign electronic Case Report Forms (CRFs). The role determines the access. Staff should also be able to briefly describe how an audit trail captures metadata that show what data were entered/altered, by whom, and when. (And someone, though not everyone, needs to be able to demonstrate how the audit trail can be used to piece together the “story of the data.” That, however, is too much to ask from our one-pager.)

Validation 101

It would be unusual for site personnel to have detailed knowledge of Computer System Validation (CSV) activities. Nevertheless, the one-pager could include a single line that confirms that the system was validated and by whom. A contact number could be included in case a regulator asks for more information or wants to see validation documents.

Where’s The Data?

Regulators will often ask where system data are stored. The answer to that question can be a simple sentence: The data are hosted by the EDC vendor at such-and-such location, or stored at the CRO, or sit on a local server within the site’s IT department.

Finally, the last line of our one-pager could be a simple statement prepared by the sponsor, CRO, or vendor, confirming that the data are protected wherever they are being stored. The data center is secure and environmentally controlled; the data are backed up to protect against loss; the system is accessed via the web through an encrypted channel -- whatever protections apply.

Conclusion

Regulators are increasingly focused on the integrity of study-related data, and that means added scrutiny of electronic systems and records. More inspections are being conducted mid-study so regulators can evaluate and ask about live systems in current operation. It’s very difficult for sites to field these questions without help from the organizations who make the decisions and have the expertise.

It’s okay to tell an inspector, “I don’t know.” (And it’s always preferable to admit that than to improvise an answer.) But say it too many times, and it casts doubt on a site’s ability to produce and maintain reliable study data. That’s in no one’s interest.

It shouldn’t be overly burdensome to develop a one-page summary sheet for each system so site personnel can address an inspector’s questions on the spot. The Investigator Meetings or Site Initiation Visits would be a good opportunity for sites to raise this point with their sponsors/CROs.

Lisa Olson will be giving an encore presentation of “Developing a Part 11 Compliance Plan in Clinical Research,” on March 24th. She describes all the elements that regulators and clients will be expecting, and since sponsors and CROs can’t implement everything all at once, Lisa prioritizes the activities necessary for developing your plan. You can register for the online course, sponsored by the Life Science Training Institute, here. Use the promotion code olson to receive a 10% discount.

Menarini adds Stemlineâs lead product, Elzonris, and its presence in the US with buyout deal.

Marc Lipsitch, a professor of epidemiology at the Harvard School of Public Health, answers questions about access to testing for COVID-19, false-negative results and the challenges of mass testing.

Yokogawa Electric Corporation (TOKYO: 6841) announces the November 15 release of ProSafe-RS R4.05.00, an enhanced version of the ProSafe-RS safety instrumented system. ProSafe-RS is a core product of the OpreX Control and Safety System family.

Yokogawa Electric Corporation (TOKYO: 6841) announces the release of Exaquantum R3.20, an enhanced version of its plant information management system (PIMS) software package in the OpreX Asset Operations and Optimization family.

Yokogawa Electric Corporation (TOKYO: 6841) announces that its control system development organization has obtained ISASecure Security Development Lifecycle Assurance (SDLA) certification from the ISA Security Compliance Institute (ISCI) .

Yokogawa Electric Corporation (TOKYO: 6841) announces that it has acquired capital in APB Corporation (APB), a pioneer in the development of a next-generation lithium-ion battery called the “All Polymer Battery,” with the aim of growing Yokogawa’s energy management system (EMS) business. The two companies have agreed that Yokogawa will provide energy management technology needed for the efficient operation and optimization of large-scale storage batteries.

Yokogawa Electric Corporation (TOKYO: 6841) announces that its subsidiary Yokogawa Turkey Industrial Automation Solutions A.S. (Yokogawa Turkey) has won an order to provide a control system and field instruments for the Zerger gas-fired power plant in Turkmenistan. The order was received from Renaissance Heavy Industries, a major construction company in Turkey that is involved in the construction of this plant for Turkmenenergo, a state-owned power utility in Turkmenistan. This is Yokogawa's first control systems order for a power plant in this country.

Yokogawa Electric Corporation (TOKYO: 6841) announces that Yokogawa Solution Service Corporation, a wholly owned subsidiary, has installed a Yokogawa control system for one of Japan's largest wind-power plants, and that this facility, Wind Farm Tsugaru, has come online. This plant was built by Green Power Tsugaru GK, a limited liability company that belongs to Green Power Investment Corporation.

Initially, the project was launched in Dhauli gram panchayat on the outskirts of Bhubaneswar and it will be implemented across the State by March 2017.

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…

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