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
Samsung Bioepis Announces Positive Preliminary Phase 1 and Phase 3 Data for SB27, a Proposed Biosimilar to Keytruda (Pembrolizumab)29.6.2026 09:19:00 CEST | Press release
Phase 1 study demonstrated pharmacokinetic (PK) equivalence between SB27 and Keytruda; Phase 3 study demonstrated equivalent objective response rate (ORR) at Week 24Phase 1 and Phase 3 studies expected to be completed within 2026 Samsung Bioepis Co., Ltd. announced today that the Phase 1 and Phase 3 studies on SB27, a proposed biosimilar to Keytruda1 (pembrolizumab), have met their primary endpoints. “We are excited to announce preliminary results from the Phase 1 and Phase 3 studies for SB27, our pembrolizumab biosimilar candidate. These topline positive results reinforce our scientific expertise and leadership in biosimilar development,” said Donghoon Shin, Executive Vice President and Head of Clinical Sciences Division at Samsung Bioepis. “We are on track to complete both Phase 1 and Phase 3 studies within this year. Leveraging our robust quality management system, we remain committed to advancing our biosimilar portfolio to broaden access to life-saving biologic medicines for patie
IQM Named a Major Player in the IDC MarketScape: Worldwide Quantum Computing 2026 Vendor Assessment29.6.2026 09:00:00 CEST | Press release
IQM today announced it has been named a Major Player in the IDC MarketScape: Worldwide Quantum Computing 2026 Vendor Assessment. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260629748732/en/ IQM named a major player in the IDC MarketScape IQM believes this recognition comes as institutions worldwide move quantum computing out of shared cloud access and into infrastructure they own and operate themselves. IQM calls this Production Quantum: full-stack, open-architecture superconducting systems deployed on premises, inside customers' own data centers and HPC environments, where organizations own the hardware, build internal expertise, and run quantum processors alongside their existing classical infrastructure. According to the IDC MarketScape, "For institutions building long-term quantum programs, this means the workflows and intellectual property developed on IQM hardware remain portable." The report further advises: "Consi
Zambon Announces Positive CHMP Opinion for Hopledo® (IPX203) for Adults with Parkinson’s Disease and Moderate to Severe Motor Fluctuations29.6.2026 09:00:00 CEST | Press release
Positive CHMP opinion is based on data from the Phase 3 RISE-PD trial, which demonstrated significantly more “Good ON” time with fewer daily doses compared with immediate-release levodopa/carbidopa More than one million people are living with Parkinson’s disease in the European Union, and over 80% experience motor fluctuations during the course of their disease, highlighting the need for additional treatment options Hopledo® contains a unique formulation combining immediate-release granules and extended-release pellets, providing both a rapid onset of action and a longer duration of effect, sustaining the levodopa therapeutic effect for a longer period of time If approved, Zambon expects to make Hopledo® progressively available to patients with Parkinson’s disease across Europe starting October 2026 Zambon today announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the granting of a marketing authorization by the European M
Enhertu® Approved in the EU as First Tumor Agnostic HER2 Directed Therapy and Antibody Drug Conjugate for Patients with Previously Treated HER2 Positive Metastatic Solid Tumors29.6.2026 08:30:00 CEST | Press release
Approval based on three phase 2 trials of Daiichi Sankyo and AstraZeneca’s Enhertu that demonstrated clinically meaningful responses across a broad range of tumors Enhertu now approved for six indications in the EU Enhertu® (trastuzumab deruxtecan) has been approved in the European Union (EU) as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2 positive (immunohistochemistry [IHC] 3+) solid tumors who have received prior treatment and who have no satisfactory treatment options. 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 approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use of the European Medicines Agency and is based on results from subgroups of patients with HER2 positive (IHC 3+) tumors across thr
Beerenberg Prevails in Patent Case Against Aspen Aerogels29.6.2026 07:00:00 CEST | Press release
The ruling confirms that Beerenberg did not infringe Aspen Aerogels’ patents. The Korean Patent Court has invalidated three of Aspen Aerogels’ patents related to improved hydrophobic aerogel material. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260628192007/en/ Beerenberg delivers high-end insulation solutions built for performance, reliability, and long-term value. (Photo: Beerenberg) The ruling confirms the conclusion of the Intellectual Property Trial and Appeal Board (IPTAB) that the patents did not meet the necessary requirements for patentability. Beerenberg, which specializes in high-end insulation products, welcomes the court’s decision. “We are pleased that the case has now been concluded and that any uncertainty regarding the infringement claims has been removed,” says CEO Arild Apelthun. About Beerenberg Beerenberg has delivered cost-efficient solutions to a wide range of industrial enterprises for 49 years. Th
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
