In this INSIDER Q&A, experts in contract manufacturing discuss aspects a brand owner should evaluate, what should be outlined in an agreement and what ongoing QA checks to conduct during the partnership.

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 ------------------------------

You know you need a computer systems audit, but that’s literally the extent of what you know.
Has this ever been you?

Yes, you use computers on a daily basis, and you may even use the system that needs to be audited. But you don’t spend your day thinking about where all the system components are located, how services and software are combined, and what Part 11 requirements apply. Terms like “cloud computing” make you feel slightly queasy. You’d rather get a root canal than discuss “distributed processing.” Your expertise is in manufacturing. Or clinical research. Or non-clinical lab operations. And somehow it’s your job to make sure an effective and properly-sized system audit is conducted. Great.



Yet your Quality Assurance colleagues -- whether they’re from your internal QA department or an external compliance company -- need your input. They need to understand what software is being purchased, what services are being contracted, how and where components of the system are being implemented, and how the system will be used.

The good news is that the QA auditors can help you. They know that FDA favors a risk-based approach to validation and Part 11 implementation, and they even know what that means. They love to talk about configuration management and change procedures. They love gathering evidence that demonstrates your system works correctly and is in a state of control, and they know what rocks they should look under to find and fix vulnerabilities.

What follows are examples of the types of information you need to convey to QA – and that they should be asking you about – to properly size and scope an audit.

How do You Plan to Use the System?

Suppose you need to audit the supplier of a new Document Management System. The first thing an auditor would need to understand is how you plan to use the system. How mission critical are the documents you’re looking to store?  Are they covered under regulatory scope?  Maybe you plan to use the system as a collaboration environment for developing new SOPs. That would require a relatively low level of scrutiny, especially if you only plan to print out the finalized documents for wet ink signature. (As a point of comparison, if you plan to use the system to finalize SOP approval, the auditor would need to check that Part 11 requirements for electronic signatures are properly implemented.) What if the Document Management System will be housing critical GxP documents, such as Trial Master Files, Master Schedule Sheets, or Master Batch Records? In these cases, the validation would have to be far more thorough, and Part 11 electronic record features, such as audit trails and archiving functionality, would have to be implemented and verified.

Here’s another “use” example. Similar to the term “Document Management System,” the term “Analytics System” does not tell the whole story. From a business perspective, study start up (SSU) metrics may be vital for sponsors and CROs to collect and analyze. But since they have no regulatory impact, the FDA would not require an SSU analytics system to be validated. (That doesn’t necessarily mean you might not want to, though.) On the other hand, a system that performs statistical analysis on study data for regulatory submission is about as critical as it gets, and would require thorough validation and Part 11 implementation. Other analytics systems, such as dashboards that pull data from critical systems, might fall somewhere between these two extremes.

What is the Vendor Providing? And How? And Where?

If you need to audit a complex system, the questions QA will ask you will go beyond system use. The auditors will need to understand the combination of software and services the vendor is providing, and where the software and data reside.

• Does the software and data reside internally at your company or does the vendor provide a hosting service?
  If the vendor is hosting, the auditor needs to tour the facilities and review SOPs and records to evaluate physical security, staff training, environmental controls, backup procedures, disaster recovery plans, data retention, computer infrastructure, and change control.
  
  
• Does the hosting vendor own its own servers or does it, in turn, outsource that function to a 3rd party hosting company, (possibly even in the cloud)?
  If the hosting is outsourced, ideally an auditor would be able to visit the hosting site. Failing that, the auditor would ask questions about the vendor’s qualification processes and review SOPs that govern vendor selection/management procedures. If the vendor outsources other services beyond hosting, those services might need to be considered, as well.
  
  
• Is the vendor providing any other services?
  Many EDC vendors will provide study-specific services such as screen development and data entry validation edits. Auditors would need to review SOPs for providing these services and understand how the vendor tests and manages modifications to these components as the study proceeds.
  Sometimes computer systems vendors provide ancillary services, such as help desk functions and user account management. That would mean additional SOPs and training records for the auditor to look through.

Other Considerations

There are many. For example, where are you in the product life cycle? You ask different questions about a new system than you would about one that has been operating for a few years. Is the product Commercial off-the-shelf (COTS) or highly customized? COTS systems vendors often have their own validation package which auditors would review, and then ensure proper operation in the sponsor/CRO’s specific environment. A highly customized or custom-built system would require a more extensive validation process.


The Take Away

CSV/Part 11 audits will never be standardized, cookie cutter type activities; there are simply too many factors -- in too many combinations -- to consider. You want your QA efforts to be worth the money you spend and be able to answer the questions FDA says you need to be asking. If you’re unsure how to do that, that’s ok. Other people know, as long as you can help them understand how you plan to use the system, what software and services are being supplied, and how components of the system are being implemented.

In case you missed it, our previous post was Notes 2 Fix Your Notes 2 File.
_______________________________________________
Many thinks to Lisa Olson for sharing her insights with me.

Third Rock Ventures, the Boston-based venture capital firm behind some of the Bay State’s most prominent biotechs, has reclaimed its title as the biggest life science-focused VC firm in the state with a new $616 million round, and has also named its first female partner in eight years. With the announcement of its Fund IV today — its largest ever — the firm now has raised $1.9 billion in the nine years since it was formed. That eclipses its rival across the Charles River, Flagship Ventures,…

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.

###

 

Under the agreement, AZ will develop, manufacture and distribute the vaccine that has already begun Phase I trials.

Earlier this month I published a blog posting that raised questions related to the potential for disruption of approvals in the wake of FDA actions to limit inspections due to the COVID-19 pandemic. Subsequently I had the opportunity to pose … Continue reading →

With the COVID-19 impact making itself apparent on a daily basis as the numbers climb and organizations respond, the effects on the pharma and biotech sector also shifts. Yesterday FDA announced a new concentration of agency assets to be focused … Continue reading →

In response to written questions submitted last month regarding the potential for delays, FDA had stated that “CDER remains fully capable to continue daily activities, while responding to the public needs of the current COVID-19 outbreak.” In a subsequent blog … Continue reading →

by ProPublica

The Pulitzer Board announced Monday that two series published by ProPublica were awarded Pulitzer Prizes. “Lawless,” a ProPublica Local Reporting Network project by the Anchorage Daily News that revealed how indigenous people in Alaska are denied public safety services, was awarded the prize for public service. “Disaster in the Pacific,” an investigation on the staggering leadership failures that led to deadly accidents in the Navy and Marines, won a national reporting prize. The two designations are ProPublica’s 6th Pulitzer win in 12 years and the first Pulitzer awarded to a Local Reporting Network partner.

Led by Daily News reporter Kyle Hopkins, “Lawless” was the first comprehensive investigation to lay bare Alaska’s failing, two-tiered justice system in which Native villages are denied access to first responders. In much of rural Alaska, villages can only be reached by plane, and calling 911 to report an emergency often means waiting hours or days for help to arrive.

The series evolved from a string of stories that Hopkins reported in 2018 for the Daily News, recounting horrific incidents of sexual assault in Alaska — which has the nation’s highest rate of sexual violence — and policing failures that have allowed offenders to continue the abuse with impunity. To fully investigate issues of lawlessness and sexual assault in the most remote communities in the U.S., the Daily News applied to participate in ProPublica’s Local Reporting Network. The program partners with newsrooms across the country, paying the salary and a stipend for benefits for local reporters who spend a year tackling big investigative stories that are crucial to their communities. Participating reporters work with a ProPublica senior editor and receive support, including from ProPublica’s data, research and engagement teams.

The collaboration’s first story, based on more than 750 public records requests and interviews, found that one in three rural Alaska communities has no local law enforcement of any kind. These indigenous communities are also among the country’s most vulnerable, with the highest rates of sexual assault, suicide and domestic violence. The series’ second major installment found that dozens of Alaska communities, desperate for police of any kind, hired officers convicted of felonies, domestic violence, assault and other offenses that would make them ineligible to work in law enforcement or even as security guards anywhere else in the country.

Next, Hopkins revealed how the state’s 40-year-old Village Public Safety Officer Program, designed to recruit villagers to work as life-saving first responders, has failed by every measure. Alaska had quietly denied funding for basic recruitment and equipment costs for these unarmed village officers while publicly claiming to prioritize public safety spending. “Lawless” also exposed how the Alaska State Troopers agency, created to protect Alaska Native villages, instead patrols mostly white suburbs surrounding cities on the road system like Wasilla. The series ended with a list of six practical solutions to Alaska’s law enforcement crisis, based on interviews with experts, village leaders, the Alaska congressional delegation and sexual assault survivors.

The Daily News and ProPublica faced a number of challenges in reporting the series. The first: No one knew which remote Alaska villages had police officers of any kind. So they built the first-ever statewide policing database by drawing on payroll, arrest and hiring records from communities spread across the state. They also contacted every village city government, sovereign tribal administrator and Alaska Native corporation in the state — more than 600 organizations.

The vastness of the state and the fact that 80% of communities aren’t on the road system posed another challenge. Journalists flew hundreds of miles, sleeping on the floors of schoolhouse libraries and riding in sleds and on snowmobiles. To aid the reporting, they also held a community meeting in Kotzebue, Alaska, where a 10-year-old girl had been raped and murdered in 2018, providing residents, advocates, tribal leaders and law enforcement their first chance for a public discussion on sexual violence. Throughout the year the reporters spoke to more than 300 people across the state.

Following publication of the first major story, U.S. Attorney General William Barr visited the state and declared the lack of law enforcement in rural Alaska to be a federal emergency. The declaration led the Department of Justice to promise more than $52 million in federal funding for public safety in Alaska villages. The U.S. Attorney’s Office in Anchorage announced the hiring of additional rural prosecutors, while Gov. Mike Dunleavy said the state will post 15 additional state troopers in rural Alaska. In addition, the Alaska Police Standards Council has proposed changing state regulations that govern the hiring and screening of village police officers, and Alaska legislators proposed legislation that would increase pay for VPSOs and overhaul funding of the program.

The Daily News’ Loren Holmes, Bill Roth, Marc Lester, David Hulen, Anne Raup, Vicky Ho, Alex Demarban, Jeff Parrott, Michelle Theriault Boots, Tess Williams, Tegan Hanlon, Zaz Hollander, Annie Zak, Shady Grove Oliver and Kevin Powell, as well as ProPublica’s Charles Ornstein, Adriana Gallardo, Alex Mierjeski, Beena Raghavendran, Nadia Sussman, Lylla Younes, Agnel Philip, Setareh Baig and David Sleight also contributed to the series.

“The ProPublica Local Reporting Network was started to give local newsrooms across America the resources and support they need to execute investigative journalism that digs deep and holds power to account,” Ornstein, a ProPublica deputy managing editor, said. “This powerful collaboration with the Anchorage Daily News investigation does exactly that, going far beyond reporting on isolated incidents to provide meticulous research and context on how the justice system has failed Alaska’s most remote and vulnerable communities. Most importantly, it has been a force for real change.”

In their “Disaster in the Pacific” series, ProPublica reporters T. Christian Miller, Megan Rose and Robert Faturechi centered on three deadly accidents in the Navy and Marines in 2017 and 2018. They exposed America’s vaunted 7th Fleet as being in crisis with broken ships and planes, poor training for and multiple warnings ignored by its commanders. The costs: 17 dead sailors in crashes involving Navy warships, and six Marines killed in a training accident.

The back-to-back accidents in 2017 and 2018 gained initial attention from Congress and the national media, but they had been told an incomplete, misleading and dangerous story of half-truths and cover-ups. ProPublica’s series provided the first full accounting of culpability, tracing responsibility to the highest uniformed and civilian ranks of the Navy. The reporting team spent 18 months on the investigation, obtaining more than 13,000 pages of confidential Navy records and interviewing hundreds of officials up and down the chain-of-command.

The first article in the series, “Fight the Ship,” reconstructed a 2017 crash involving the USS Fitzgerald, one of the deadliest accidents in the history of the Navy. The story showed that the accident was entirely preventable, and that the Navy’s senior leadership had endangered the warship by sending a shorthanded and undertrained crew to sea with outdated and poorly maintained equipment. To show readers what happened, ProPublica hired designer Xaquín G.V. Working with investigations producer Lucas Waldron, Xaquín used geodata on the ships’ locations, mapped the path of each vessel and created a graphic that simulated the crash, down to the moment the Fitzgerald was sent spinning out of control, rotating 360 degrees. The team also collected radar images, ship blueprints, hand-drawn images made by surviving sailors and video taken inside the ship, which allowed them to portray the disaster from the perspective of the sailors onboard.

A second story, “Years of Warnings, Then Death and Disaster,” detailed how the fatal crash of the USS Fitzgerald, and of the USS McCain weeks later, were the result of a congressional gutting of the Navy and the Navy’s prioritization of building new ships. Top Navy officials gave urgent, repeated warnings to Navy Secretary Ray Mabus about the deadly risks facing its fleet, including being short of sailors, sailors poorly trained and worked to exhaustion, warships physically coming apart, and ships routinely failing tests to see if they were prepared to handle warfighting duties. They were ignored, told to be quiet or even ordered to resign.

Another story captured the Marine Corps multiple failures that were responsible for the deaths of six men in a nighttime training exercise 15,000 feet above the Pacific — an accident that senior leaders had been warned was possible, even likely. ProPublica created an animated short documentary, using a combination of an on-camera interview, 3D animation, 2D illustration and atmospheric footage to bring the excruciating hours of a needless tragedy to light. Through extensive interviews with eyewitnesses, the team reconstructed the moments leading up to the crash, the crash itself and the botched search and rescue effort.

The series also illuminated how the Navy’s reckless management of the 7th Fleet was measured not only in fatalities, but also in the hurt and shame of the rank-and-file sailors whom the Navy blamed and prosecuted for the accidents. The Navy’s prosecution of Navy Cmdr. Bryce Benson for what were clearly systemic shortcomings, traceable all the way to the Pentagon, left many of its own furious and demoralized.

Weeks after the first story’s publication, the House Armed Services Committee convened a panel to challenge senior Navy leaders over their claims that they had been fully truthful about its failings and its efforts at reform. The reporting forced the Navy to admit to Congress that its claims about its rate of progress on reform were misleading. In light of ProPublica’s reporting on the improper role that the Navy’s top commander played in the prosecution of Benson, one of captains on the USS Fitzgerald, the Navy dropped all criminal charges. U.S. and NATO Navy commands throughout the world have ordered sailors and officers to read the ProPublica accounts as part of training and education.

Joseph Sexton, Tracy Weber, Agnes Chang, Katie Campbell, Joe Singer, Kengo Tsutsumi, Ruth Baron, David Sleight, Sisi Wei, Claire Perlman, Joshua Hunt and Nate Schweber also contributed to this series.

“The Navy actively blocked reporting at every step, with communications officers attempting to dissuade officials from conducting interviews with ProPublica and leaking positive stories to competing media outlets in an attempt to front-run our stories,” ProPublica Managing Editor Robin Fields said. “The military even threatened that we could be criminally prosecuted for publishing the material we obtained. This tour de force of investigative journalism is a testament to the unflinching tenacity of the reporters and the innovation of ProPublica’s data, graphics, research and design teams. Their essential work laid bare the avoidance of responsibility by the military’s most senior leaders.”

After penning a deal with Eli Lilly last month with the aim to have an antibody in the clinic within four months, Canadian-based AbCellera has been given a financial boost by its government.

Here is where masks are currently required, as well as proposals that would dramatically increase face-covering requirements.

California's deal with Bear Mountain Development Co. for coronavirus equipment was one of the state's largest.

On March 25, 2020, Hitachi Capital Corporation, Yokogawa Electric Corporation (TOKYO: 6841), and amnimo Inc., a subsidiary of Yokogawa, entered into a comprehensive partnership agreement with an aim to provide new services by adding Industrial IoT ("IIoT") to each company's technologies, know-how, and lease equipment.

Yokogawa Electric Corporation (TOKYO: 6841) announces that on April 8, it completed the acquisition of all shares of Fluid Imaging Technologies, Inc., as mutually agreed.

Adamas Asset Management (AAM) has named Brock Silvers as its chief investment officer with immediate effect.

The post People Digest: Adamas Asset appoints CIO; Withers gets HK partner appeared first on DealStreetAsia.

Ruangguru CEO Adamas Belva Syah Devara has resigned from its role as the government's special staff.

The post Indonesia Digest: Ruangguru CEO quits govt role; Gojek partners Paxel appeared first on DealStreetAsia.

SoftBank Vision Fund has started to rope in specialists to lead its efforts in China as early as 2018.

The post Gaocheng Capital founding partner Daisy Cai joins SoftBank Vision Fund appeared first on DealStreetAsia.

Teo's firm Straits VC is slated to focus on early-stage healthcare opportunities in Asia.

The post B Capital’s Gavin Teo departs to set up healthcare VC firm appeared first on DealStreetAsia.

It's SG growth & marketing director, Sarah Tan, will take over the reins as interim general manager.

The post Deliveroo’s Singapore GM departs, one quarter of employees in city-state laid off appeared first on DealStreetAsia.

Wihardja’s appointment comes nine months after his predecessor, former MDI Ventures CEO Nicko Widjaja, quit to join BRI Ventures.

The post Indonesia’s MDI Ventures appoints former AC Ventures partner Donald Wihardja as CEO appeared first on DealStreetAsia.

In vitro and mouse studies suggest inhibiting TRIM37 could help treat breast cancer.

May 7, 2020

History is replete with irony, but rarely more poignantly than in the summer of 2016 when, on 23 June, the UK voted to leave the European Union and the next day, 24 June, the EU published its Global Strategy document asserting its ambition of “strategic autonomy.” Whither Franco-British defense cooperation in such chaotic circumstances? This paper attempts to provide the outline of an answer to that question.

Gómez-Hernández, José-Antonio . Leer, escribir y aprender con Internet. La función educativa de las bibliotecas y las tecnologías participativas de la web social., 2008 In: Infodiversidad. La biblioteca como centro multicultural. Universidad de Guadalajara, pp. 55-74. [Book chapter]

May 7, 2020

History is replete with irony, but rarely more poignantly than in the summer of 2016 when, on 23 June, the UK voted to leave the European Union and the next day, 24 June, the EU published its Global Strategy document asserting its ambition of “strategic autonomy.” Whither Franco-British defense cooperation in such chaotic circumstances? This paper attempts to provide the outline of an answer to that question.

May 7, 2020

History is replete with irony, but rarely more poignantly than in the summer of 2016 when, on 23 June, the UK voted to leave the European Union and the next day, 24 June, the EU published its Global Strategy document asserting its ambition of “strategic autonomy.” Whither Franco-British defense cooperation in such chaotic circumstances? This paper attempts to provide the outline of an answer to that question.

May 7, 2020

History is replete with irony, but rarely more poignantly than in the summer of 2016 when, on 23 June, the UK voted to leave the European Union and the next day, 24 June, the EU published its Global Strategy document asserting its ambition of “strategic autonomy.” Whither Franco-British defense cooperation in such chaotic circumstances? This paper attempts to provide the outline of an answer to that question.

Leander Paes on how he keeps himself fit at 40, and his interest in films.

May 7, 2020

History is replete with irony, but rarely more poignantly than in the summer of 2016 when, on 23 June, the UK voted to leave the European Union and the next day, 24 June, the EU published its Global Strategy document asserting its ambition of “strategic autonomy.” Whither Franco-British defense cooperation in such chaotic circumstances? This paper attempts to provide the outline of an answer to that question.

Apr 2, 2020

Dear America,

In London there is much talk of a new “spirit of the Blitz” in the face of another deadly threat to us all.

But 80 years on, that spirit is expressing itself very differently. When the Luftwaffe bombs fell, to continue with normal life was an act of patriotic defiance. Now as COVID-19 spreads, to continue with normal life is an act of punishable deviance.

May 7, 2020

History is replete with irony, but rarely more poignantly than in the summer of 2016 when, on 23 June, the UK voted to leave the European Union and the next day, 24 June, the EU published its Global Strategy document asserting its ambition of “strategic autonomy.” Whither Franco-British defense cooperation in such chaotic circumstances? This paper attempts to provide the outline of an answer to that question.

Mar 3, 2020

Trump must balance the critical military and economic ties the United States is building with India against the repudiation by the Modi government of the very principles that are at the foundation of the friendship itself.

Learn how to store data using the Parse JavaScript API and the PhoneGap mobile framework.

Learn how to add offline support, geolocation, and child browser features using the Parse service in PhoneGap.

Mar 3, 2020

Trump must balance the critical military and economic ties the United States is building with India against the repudiation by the Modi government of the very principles that are at the foundation of the friendship itself.

May 7, 2020

History is replete with irony, but rarely more poignantly than in the summer of 2016 when, on 23 June, the UK voted to leave the European Union and the next day, 24 June, the EU published its Global Strategy document asserting its ambition of “strategic autonomy.” Whither Franco-British defense cooperation in such chaotic circumstances? This paper attempts to provide the outline of an answer to that question.

May 7, 2020

History is replete with irony, but rarely more poignantly than in the summer of 2016 when, on 23 June, the UK voted to leave the European Union and the next day, 24 June, the EU published its Global Strategy document asserting its ambition of “strategic autonomy.” Whither Franco-British defense cooperation in such chaotic circumstances? This paper attempts to provide the outline of an answer to that question.