PQE-GROUP
25.6.2024 17:21:35 CEST | Business Wire | Press release
PQE Group, a leading consultancy in the Life Science sector, announces the consolidation of its new Regulated Artificial Intelligence & Data Analytics division operating since the initiation of AI based tools in the industrial space. This marks a pivotal step in the company's evolution, positioning the Italian Group, comprised of more than 2000 employees, at the forefront of technological innovation in Life Sciences. The new division is designed to enhance business process efficiency and effectiveness while ensuring regulatory compliance. Leveraging advanced technologies, PQE Group offers services like AI-driven decision optimization, risk reduction, and accelerated innovation, all adhering to industry regulations. The 2024 Stanford Report on AI highlighted AI's significant role in accelerating scientific discovery in 2022, with further strengthening in 2023.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240625598895/en/
Danilo Neri - Partner & Vice President Executive at PQE Group (Photo: PQE Group)
“Regulators have started addressing the expectations for these solutions, but there is still much to do, since regulated companies need detailed guidance on documentation required to ensure explainability and performance of each tool," emphasized Danilo Neri, Partner & Vice President Executive of PQE Group. "Just a few weeks ago, the final approval of the AI Act in the European Union was granted, representing the world's most advanced regulation on artificial intelligence, requiring documentation to address explainability. It is an important step, but it is equally important that penalties are effectively applied to offenders to not compromise consumer, worker, and citizen protection at the expense of innovation and market competitiveness. The full establishment of this division will allow us to consolidate our position as a leader in the sector, offering exceptional compliance approaches and tailor-made solutions to our clients that meet regulatory expectations and the increasingly complex market needs." PQE Group’s dedicated validation approach has been designed to meet the current regulatory expectations for machine learning-based tools and for Generative AI solutions.
PQE Group's partnership with the Canadian company GenAIz will further boost service capacity. GenAIz, focused on the use of AI for supporting humanity, has developed a platform to speed up decision-making and execution with better business insights. This collaboration will enhance PQE Group's ability to offer innovative solutions and the necessary validation packages required by GxP regulations and by incoming industry wide rules (e.g., European AI act). Led by Catherine Lunardi, CEO of GenAIz and a spokesperson at the G7 on AI and wellbeing, GenAIz's AI platform will leverage PQE Group's global presence, which includes more than 45 offices worldwide.
The Regulated Artificial Intelligence & Data Analytics division will be presented in a panel discussion and networking event in Rockville, MD, on July 17, 2024. Experts will discuss AI regulations and the future of life sciences, marking a significant innovation for the pharmaceutical and medical device industry.
The press and readers are warmly invited to the event.
Please confirm attendance and find more information by registering here: https://hubs.ly/Q02CMQrj0
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240625598895/en/
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
International Human Rights Lawyer Jared Genser and Former White House Counsel Lanny J. Davis Join Legal and Advocacy Team Supporting Cambodian Businessman Yim Leak, Seiden Law LLP Announces18.9.2026 19:52:00 CEST | Press release
Jared Genser, one of the world's most recognized international human rights lawyers, and Lanny J. Davis, an adviser to former presidents George W. Bush and Bill Clinton, join the legal and advocacy team for Cambodian businessman Yim Leak and challenge what they call a coordinated smear campaign in Thailand. International human rights lawyer Jared Genser and Lanny J. Davis, who has close ties to two former US presidents and a worldwide reputation for defending those under attack with lies and smears, and for repairing the damage done to their reputations, have joined the legal and advocacy team supporting Cambodian businessman Yim Leak, Seiden Law LLP, which serves as Yim Leak's chief global counsel, announced today. Their first move is to hold the Thai government accountable, framing its conduct as either complicit in or willfully blind to a sustained smear campaign against Yim. Genser is Managing Director of Perseus Strategies, an international law firm. Over more than two decades, he
Ningbo FEED Meeting Confirms Full Confidence in Q1 2027 FID for Allied Biofuels’ US$6.1 Billion Presidential Decree-Backed SAF and e-SAF Project18.9.2026 17:38:00 CEST | Press release
Allied Biofuels has held a major Front-End Engineering Design (FEED) meeting at Sinopec’s office in Ningbo, China, bringing together Allied Biofuels, Sinopec Engineering Group Co., Ltd. of China, Topsoe A/S of Denmark, Sasol South Africa Limited, and Plug Power of the United States — the principal international engineering and technology providers supporting its US$6.1 billion Presidential Decree-backed Sustainable Aviation Fuel (SAF) and e-SAF project in Uzbekistan. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260918708077/en/ FEED Meeting - Ningbo, China At the joint FEED meeting of the project’s core engineering and technology stakeholders, the discussions established clear alignment on engineering responsibilities, technology interfaces, design deliverables, project integration and the coordinated execution programme required to advance the project through FEED. All stakeholders working on the project expressed full co
Corcept Announces CHMP Opinion Recommending EU Marketing Authorization for Lifyorli® (Relacorilant)18.9.2026 14:00:00 CEST | Press release
Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended that the European Commission (EC) should approve relacorilant, combined with the chemotherapy drug nab-paclitaxel, for the treatment of patients with platinum-resistant ovarian cancer. The CHMP’s recommendation is based on positive data from Corcept’s Phase 2 and pivotal Phase 3 ROSELLA trials, in which patients receiving relacorilant combined with nab-paclitaxel experienced improved progression-free and overall survival compared to patients who received nab-paclitaxel alone. The safety profile of relacorilant plus nab-paclitaxel in these trials was consistent with the safety profile of nab-paclitaxel monoth
Enhertu® Recommended for Approval in the EU by CHMP as Adjuvant Treatment for Patients with Residual Disease After Neoadjuvant Treatment for HER2 Positive Early Breast Cancer18.9.2026 14:00:00 CEST | Press release
Recommendation based on DESTINY-Breast05 phase 3 trial results that showed Enhertu reduced the risk of invasive disease recurrence or death by 53% versus T-DM1 Daiichi Sankyo and AstraZeneca’s Enhertu has the potential to become a new standard of care in this early breast cancer setting Enhertu® (trastuzumab deruxtecan) has been recommended for approval in the European Union (EU) as a monotherapy for the adjuvant treatment of adult patients with resected HER2 positive breast cancer who have residual invasive disease after neoadjuvant taxane-based and HER2 targeted treatment. Enhertu is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/NYSE: AZN). The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on results from the DESTINY-Breast05 phase 3 trial presented at th
CHMP Recommends EU Approval of New Indication for Alfasigma’s Jyseleca® (filgotinib), Treatment of Adults With Axial Spondyloarthritis18.9.2026 12:58:00 CEST | Press release
The information contained within this press release is for the purpose of scientific exchange.It is intended for scientific, financial and investor media only.If approved, Jyselecawill be indicated for the treatment of patients with active axial spondyloarthritis (axSpA), both non-radiographic and radiographic forms of the disease, who have responded inadequately to conventional therapy.Despite the availability of multiple treatment options, nearly half of people living with axSpA do not respond adequately to current therapies, and just 10-20% reach inactive disease within 16-24 weeks of initiating treatment.CHMP’s positive opinion is based on findings from the OLINGUITO Phase 3 study, where improvements in the signs and symptoms of axSpA with filgotinib were observed early and maintained over 52 weeks of treatment.Jyselecais already approved in Europe and the United Kingdom, for the treatment of moderate to severe rheumatoid arthritis and ulcerative colitis. Alfasigma S.p.A, a global
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom