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Overview

Ensuring quality of the health product ensures its safety and efficacy. Manufacturers in low-
and middle-income countries (LMICs) face challenges to achieve quality in local production,
such as the lack of an available manufacturing workforce trained in quality and understanding
regulatory quality standards and difficulties in implementing a quality culture in the
manufacturing facility.
The Local Production and Assistance (LPA) Unit in the Innovation and Emerging Technologies
Department (IET), Access to Medicines and Health Products Division (MHP), WHO, supports
Member States (MS), particularly LMICs, to strengthen sustainable local production and
technology transfer to improve timely, equitable access to quality, safe and effective essential
medical products.

The LPA Unit provides assistance and support to MS with an ecosystem
wide and holistic approach, such as conducting ecosystem assessments for sustainable,
quality local production, developing and implementing strategies, roadmaps and tools,
providing comprehensive capacity building and technical assistance, including for WHO
Prequalification (PQ)/Emergency Use Listing (EUL), and facilitating technology transfer (TT).

To support MS to overcome challenges to locally produce quality-assured vaccines and
biotherapeutics, medicines and in vitro diagnostics (IVDs), the LPA Unit organized a new
global training event – Week of Quality – to complement the annual Virtual cGMP Training
Marathons also organized by the LPA Unit. The first Week of Quality was organized from 16 to
20 June 2023 and focused on establishing quality specifications of vaccines, medicines and
IVDs based on WHO and other international guidelines, one of the stepping stones to
achieve quality.

The second week of quality took place from 15 April to 13 June 2024 and
focused on exploring key aspect of regulatory compliance for Medicines, IVDs and Vaccines
and biotherapeutics. More than 1700 vaccine and biopharmaceutical manufacturers and
regulators attended the sessions on key aspects of vaccine and biotherapeutic
regulatory compliance. More than 1400 pharmaceutical manufacturers and
regulators strengthened their knowledge on quality requirements for pharmaceutical
product development. And for the first time, over 1000 IVD manufacturers and
regulators, built capacity in principles of design, quality and compliance for optimizing IVD
product development.

Questions raised by manufacturers and regulators in the second Week of Quality have been
assembled in this training material with questions-and-answers (Q&A) with answers prepared
and peer-reviewed by experts with long and rich experience in the vaccine, medicine or IVD
industry, national regulatory authority (NRA), and other organizations. This document has
been developed to provide manufacturers and other relevant stakeholders with a continuous
learning resource and reference document to acquire new and fortify existing, knowledge
and capacities to strengthen the local production of quality vaccines, medicines and IVDs.

Three very different companies have now confirmed data breaches affecting millions of users – each insisting the damage stopped well short of passwords and payment details.

Pornhub has told Premium subscribers that some user data was exposed after a breach at Mixpanel, a third-party analytics provider it once used, rather than through any compromise of Pornhub’s own systems.

In a notice to users, the adult site said the incident affected “only select Premium users” and involved a limited set of analytics events inside Mixpanel’s environment. Pornhub stressed that passwords, credentials, payment details, and government IDs were not exposed, and noted it stopped working with Mixpanel in 2021 but was informed of the breach by the vendor.

The disclosure follows a similar incident last week affecting OpenAI, which traced a leak of internal data to compromised Mixpanel analytics credentials.

SoundCloud has also confirmed it was breached after a week of user complaints about outages and broken access, which the company now says were linked to a cybersecurity incident. The streaming platform said it detected unauthorized activity in an ancillary service dashboard and brought in third-party security experts to investigate, eventually determining that the exposure affected roughly 20 percent of users.

According to public data, SoundCloud has approximately 140 million users, suggesting that some 28 million people have likely been affected by the breach.

According to SoundCloud, the data accessed was limited to email addresses and information already visible on public profiles, and did not include passwords or financial details. But the measures taken to contain the breach had side effects. Configuration changes introduced during the response caused “temporary connectivity issues” for some users, particularly those accessing the service via VPNs, effectively turning a behind-the-scenes security incident into a very public service disruption.

Over in Japan, retail giant Askul is still picking through the wreckage of an October ransomware attack that knocked systems offline and exposed customer data. In a new report [PDF], the office supplies and e-commerce giant said the incident caused “large-scale service stoppage” and confirmed that information it held “flowed outside the company” after its network was compromised.

In the report, translated by The Register, Akira Yoshioka, president and CEO of Askul, confirmed “the recent ransomware attack resulted in the leak of customer information, as well as the information of some of our business partners, and we apologize for the significant inconvenience and concern this has caused.”

Askul now says roughly 740,000 records linked to individual customers and corporate clients were affected, with some affected data published by the RansomHouse cybercrime crew, but says no financial details were accessed during the attack.

The lengthy report confirms that threat actors accessed Askul’s internal systems using the login details of a subcontractor “who exceptionally did not apply multi-factor authentication.” The firm also admits that the datacenter where the breach occurred “did not have EDR installed on its servers, nor was 24-hour monitoring performed, so unauthorized access and intrusion could not be detected immediately.”

Ransomware infection was confirmed in logistics and internal systems, and some data (including backups) was encrypted and rendered unusable. In addition, some of that data was stolen and leaked by the attacker.

Different sectors, different attackers, and very different root causes – but the same end result: user data escaping through analytics tools, ancillary systems, and ransomware-ridden networks, even as companies rush to reassure customers that the most sensitive details stayed put. ®

The Hartlepool Supported Internship Programme – a partnership between Hartlepool Borough Council, consultancy DFN Project Search and local employers – provides a structured, work-based learning programme to help young people aged 16-24 with additional needs and/or autism gain the skills, experience and confidence they need to move into paid employment.

The scheme has received another major boost after Asda Hartlepool joined the partnership – the first time the Hartlepool store has done anything like this.

Asda has welcomed nine young people into supported internships, with them each spending time learning the ropes in a range of different store areas including fresh and frozen food, George, health and beauty and general grocery items over a total nine month period.

As well as trying out different job roles in real working environments, the interns learn practical skills, timekeeping and communication, discover what kind of work they are good at and build their confidence and independence, all the time continuing with education and training and receiving support from job coaches and mentors.

Just a few weeks into their placements, the interns and Asda are already seeing major benefits.

Noah Hunter, who is 19, said: “I’m really enjoying it – it gives me a reason to come out of the house. It lets me do work and I’m really enjoying doing that.

“It’s made me more confident and has helped me improve my timekeeping. The staff in Asda are really nice and are always there if you need a helping hand.”

Aimee Mitchell, who is 20, said: “I am enjoying it – I feel good coming into work every morning and I’m proud of myself and happy, and I’m looking forward to the next few months.”

Councillor Aaron Roy, Vice-Chair of Hartlepool Borough Council’s Adult Services and Public Health Committee, said: “We were absolutely delighted to welcome Asda Hartlepool to the partnership – it’s testament to the confidence employers have in the Supported Internships scheme.

“For people with additional needs and/or autism, gaining and sustaining employment can often be far more difficult than for those who don’t have them, and these internships help change lives, building independence and confidence and showcasing the young people’s drive and determination.

“They are also good for business, increasing an employer’s confidence to develop employees with additional needs and increasing the diversity of the workforce, reflecting its customer base. We’d love more firms to follow Asda’s lead and come onboard.”

Rob Cecere, Asda Hartlepool General Store Manager, said: “Comparing how the interns were on day one when they first came in for the interviews with now just a few weeks later, we’ve already seen how they’ve grown, with their potential and passion shining through.

“We’re so excited to support this project and we’re really looking forward to the coming months and seeing how these young people continue to flourish.”

Beth Madigan, Programme Specialist for DFN Project Search, said: “We know that supported internships can change lives but we also know that it can really benefit a business and they can make use of an untapped talent pool.

“We’re really excited to see the ripple effect of this programme in Hartlepool, benefitting the community and raising aspirations for young adults with additional needs and/or autism and building a more inclusive workforce in the community.”

If you’re a Hartlepool business keen to get involved – or if you’re someone who would like to join one of the Supported Internships programmes – email SI@hartlepool.gov.uk