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The FDA (Food and Drug Administration) Drug Approval Process Training Course: A Practical Insight into FDA Requirements

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Dublin, May 22, 2023 (GLOBE NEWSWIRE) — The “The FDA (Food and Drug Administration) Drug Approval Process Training Course” conference has been added to ResearchAndMarkets.com’s offering.

The US is the largest market globally for pharmaceutical sales, so having a good understanding of FDA procedures is vital for those submitting in this challenging region.

This course will help clarify the US regulatory process, giving you a practical insight into FDA requirements and ensuring that you are fully up to date with all the latest developments.

The comprehensive programme will cover procedures for submission of INDs, NDAs, ANDAs and 505(b)(2), provide a useful insight into the organisation and structure of the FDA and its review processes, and highlight recent changes.

The course will emphasise areas of interest to innovative manufacturers, but will also deal with issues relating to generic and over-the-counter drugs.

There will be ample opportunity for discussion with our expert trainer as well as other delegates and a practical workshop session to optimise learning.

Benefits of attending:

  • Review the latest FDA regulatory requirements for drug development
  • Understand FDA regulatory strategic needs
  • Ensure that you comply with FDA requirements for NDAs, ANDAs and 505(b)(2)
  • Discuss recent changes and developments with an industry expert and Improve your communication and interactions with the FDA

Who Should Attend:

This programme will be especially beneficial to those responsible for preparing US registration documents (INDs, NDAs, Biologics License Applications, etc), regulatory affairs personnel, lawyers and others responsible for advising companies on strategies for developing new drugs for the US market.

Key Topics Covered:

Day 1

Pharmaceutical Medicine and Documents

  • The role of regulatory affairs
  • The purpose of the Common Technical Document (CTD)

FDA History and Organisation

  • Review of FDA centers
  • Organization of the CDER and CBER
  • Differences between CDER and CBER

Legal Basis (Patent Exclusivity PDUFA, GDUFA, BsUFA)

  • 21st century cure act
  • Patent and exclusivity
  • PDUFA
  • GDUFA
  • BsUFA

Legal Basis Continued

Application and Submissions Types

  • Investigational new drugs (IND)
  • New drug applications (NDA)
  • Abbreviated new drug applications (ANDA)
  • Over the counter drugs (OTC)
  • Biologics license applications (BLA)
  • Orphan drug designations

Refusal to File

  • Reasons for refusal
  • The regulatory process

Investigational New Drug (IND) Applications

  • Review of the content of an IND

Getting Products to the Market Faster

  • Review of expedited programs in the US
    • Fast Track designation
    • Breakthrough Therapy designation
    • Accelerated Approval
    • Priority Review designation

FDA Meetings and Documentation

  • FDA communication philosophy
  • Different meeting types
    • Scope
    • Format
    • Procedure

CTD Content – Setting the Scene

  • Lean authoring to ensure possible document re-use for multiple purposes
  • A review of the different modules

CTD Content – M1

Day 2

CTD Content – M3 and Corresponding M2

CTD Content – M4 and Corresponding M2

CTD Content – M5 and Corresponding M2

Submission Format and Methods

  • Study tagging files
  • Datasets
  • Case report forms
  • Bioresearch monitoring (BIMO) clinical data

US Amendment Procedures

  • A review of US amendment procedures (incl. annual reports, minor/major changes)

High Level Comparison US vs EU

  • A review of the main differences in terms of dossier content and procedures

Case Study

Speakers:

Hans van Bruggen
Qdossier

Hans van Bruggen is CEO of and Senior Regulatory Affairs Scientist at Qdossier. He holds an MSc. in Pharmaceutical Medicine from the University of Surrey (UK) and has worked in the pharmaceutical industry for more than 35 years, primarily at global or European headquarters sites. He has gained a wealth of experience and a comprehensive view on what information is needed to evaluate the benefit/risk ratio of drugs for patients and healthy volunteers. He approaches interdisciplinary and international processes using that scientific background. He applies new technologies and Artificial Intelligence to facilitate the business and let people focus on what they can do best.

Marloes van der Geer
Senior Regulatory Affairs Scientist
Qdossier

Marloes van der Geer works as senior regulatory affairs scientist at Qdossier.Marloes holds a master in Life Sciences (Drug Innovation) from the University of Utrecht, the Netherlands. For nine years she held several positions at Hoffmann-la Roche in Switzerland, including the role of regulatory intelligence manager and regulatory policy lead for the EMEA region. Marloes has been actively involved in several industry associations like EFPIA and IFPMA. Also, she contributed to the ongoing IMI PREFER project in Europe, focused on the generation and use of patient preference data. In 2019, Marloes joined Qdossier.Marloes’ areas of expertise are: eCTD, lean authoring, publishing, biopharmaceuticals (incl. biosimilars), clinical development, regulatory convergence & harmonization and facilitated registration pathways (incl. orphan drugs), local RA activities (e.g. product information management).

For more information about this conference visit https://www.researchandmarkets.com/r/bvg3fn

About ResearchAndMarkets.com
ResearchAndMarkets.com is the world’s leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.


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Artificial Intelligence

Congregating in the Lion City for a Win-Win Future of Intelligent Computing at the Global Data Center Facility Summit 2024

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SINGAPORE, May 17, 2024 /PRNewswire/ — On May 17, 2024, the Global Data Center Facility Summit 2024 was held in Singapore with the theme of “Power the Digital Era Forward.” At the summit, over 600 data center industry leaders, technical experts, and ecosystem partners gathered to discuss new trends and opportunities of the global data center industry in the intelligent computing era. The attendees also got to experience all-scenario, all-ecosystem, and all-service end-to-end (E2E) solutions, share innovative practices of green data centers in the Asia Pacific and Europe, and experience the exhibition vehicle to unveil the mystery of Outdoor PowerPOD that features one power system per container. By fully embracing the intelligent computing era, Huawei strives to power the digital era forward.

Seizing Opportunities Brought by AI and Jointly Building Green & Reliable Computing Infrastructure
At the opening speech, Charles Yang, Senior Vice President of Huawei and President of Marketing, Sales and Services, Huawei Digital Power, noted that since ChatGPT ushered in the AI era, large models keep pushing the limits of computing power and the intelligent computing industry is witnessing an unprecedented construction boom. As predicted, 100 GW will be added to the global data center installed capacity and the market value will exceed US$600 billion in the next five years.
According to Charles, with opportunities come challenges. The primary challenge concerning the data center industry is reliability and electricity. Data centers are scaling up from the MW-level to the GW-level. E2E reliability of data centers is becoming even more important than ever. In response to the opportunities, Huawei will work with customers and partners to expand the industry space.
Steering Data Centers to the AI Era with Product + Service + Ecosystem
During the summit, Sun Xiaofeng, President of Huawei Data Center Facility & Critical Power Business, delivered a speech titled “Power the Digital Era Forward. ” He stated that as AI large models are penetrating, the surging compute demands drive the expansive growth in data center.
To address the challenges, Huawei strives to build product + service + ecosystem E2E data center solutions that feature fast deployment, flexible cooling, green energy, and ultimate reliability.
Fast deployment: Data centers are fully modularized and prefabricated to ensure high quality and efficient construction.Flexible cooling: Air-liquid fusion and integrated cooling source emerges as the optimal cooling architecture for intelligent computing.Green energy: New generation-grid-load-storage integrated solution is built to ensure the sound operations of intelligent computing centers.Ultimate reliability: Data centers are safeguarded through reliable products and preventive protection.Currently, Huawei’s global service network covers more than 170 countries with over 1800 professional engineers, providing 24/7 technical support. With N+ flagship service centers, Huawei has built a one-hour service radius for its customers.
The ecosystem is a key part for a win-win future of intelligent computing. Huawei works with partners to develop comprehensive E2E solutions and provide customers with one-stop data center services.
During the summit, Huawei and the ASEAN Centre for Energy released a white paper on “Building Next Generation Data Center Facility in ASEAN.” The document provides insights into the status quo, challenges, and trends of data centers in the ASEAN region, and emphasizes that efficient and energy-saving products and solutions should be applied. It also proposes future-oriented policy recommendations for data center markets.
In the ecosystem exhibition area, Huawei showcased scenario-based solutions for large-, medium-, and small-sized data centers, and demonstrated data center consulting, design, integrated development, and delivery capabilities with dozens of ecosystem partners including CIMC, Weichai, CSCEC, and Huashi.
On a special note, the Huawei Outdoor PowerPOD exhibition vehicle made its global debut. The Huawei Outdoor PowerPOD features one power system per container, outdoor deployment, plug-and-play, and high protection rating and reliability. It has become the preferred choice for decoupling the power supply architecture.
A single tree cannot make a forest.
AI is presenting great opportunities. By delving into the industry, aggregating partner ecosystems, and making innovations applicable to transformations, Huawei will continue to help customers build reliable computing infrastructure, accelerating the industry to embrace AI and powering the digital era forward.
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Artificial Intelligence

HOYA Group Company, PENTAX of America, Inc. and MAGENTIQ EYE Ltd. Announce their Intention to Form a Distribution Partnership for the U.S Market

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WASHINGTON D.C., May 17, 2024 /PRNewswire/ — HOYA Group Company, PENTAX of America, Inc. (PENTAX Medical) and MAGENTIQ-EYE Ltd., an AI medical device company, announced today their intention to form a partnership in the field of AI in Gastroenterology and to examine further collaboration and strategic partnerships.

Pending field trials and customer demonstrations to be conducted over the next several months, the companies expect to formalize an agreement as a first step in this partnership, by which PENTAX Medical will distribute the MAGENTIQ-COLO™ AI-assisted lesion detection device in the U.S.A. beginning October 1st, 2024. The system will be demonstrated at the upcoming Digestive Disease Week (DDW) in Washington D.C., U.S.A.
MAGENTIQ-COLO™ is a cutting-edge system for the detection of gastrointestinal lesions in colonoscopies. Successfully validated in an international multicenter, randomized, controlled trial (RCT) with 950 enrolled patients at 10 hospitals in Europe, United States and Israel, its outstanding diagnostic capabilities are setting new standards in endoscopic AI.
“We are excited to bring the MAGENTIQ-COLO™ device to the GI community in the U.S. Together with PENTAX Medical’s product portfolio, we are confident to provide a smart solution in colonoscopy and contribute further to colorectal cancer prevention”, says David Harrison, President PENTAX of America, Inc.
“Partnering with PENTAX Medical is an important milestone for us, as it opens new opportunities to introduce our game changing product to the U.S. market, benefiting doctors and their patients and saving more lives”, says Dror Zur, Founder & CEO of MAGENTIQ-EYE.
About MAGENTIQ-EYE Ltd.Founded in 2014, MAGENTIQ-EYE offers a groundbreaking AI-aided colonoscopy solution that offers one of the best performances known today. With worldwide recognition from the gastroenterology community, and dozens of procedures performed every day with the assistance of MAGENTIQ-COLO™, we are setting the new standard of colonoscopy, and saving more and more lives. www.magentiq.com 
About PENTAX Medical
PENTAX Medical is a division of HOYA Group. The company’s mission is to improve the standard of patient care and quality of healthcare delivery by providing the best endoscopic products and services with a focus on QUALITY, CLINICALLY RELEVANT INNOVATION, and SIMPLICITY. PENTAX Medical strives to align with the healthcare community’s Triple Aim goals through transparent partnerships with its customers and by providing the highest quality solutions to help them reach their goals, including enabling customers to improve patient outcomes by offering evidence-based solutions across the continuum of care; ensuring value by supporting the customers to improve their efficiency and minimize their healthcare costs; and enriching patient and provider’s experience by empowering every member of the care team to achieve optimal outcomes through products, education, and support. Focused on the outcome instead of technological features, PENTAX Medical listens to the healthcare community and their patients, understands their daily obstacles and helps improve endoscopy with smart innovations.
For more information: https://www.pentaxmedical.com
About HOYA
Founded in 1941 in Tokyo, Japan, HOYA Corporation is a global technology and med-tech company and a leading supplier of innovative high-tech and medical products. HOYA is active in the fields of lifecare and information technology, providing eyeglasses, medical endoscopes, intraocular lenses, optical lenses, as well as key components for semiconductor devices, LCD panels, and hard disk drives. With over 150 offices and subsidiaries worldwide, HOYA currently employs a multinational workforce of 36,000 people. For more information, please visit: https://www.hoya.com/en/

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Pearson augments nursing content with generative AI study tools to improve nursing education and address shortages

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HOBOKEN, N.J., May 17, 2024 /PRNewswire/ — Pearson (FTSE: PSON.L), the world’s leading learning company, today announced the integration of AI study tools into its Nursing: A Concept-Based Approach to Learning series, the only nursing concepts curriculum built from the ground up as a comprehensive, cohesive learning system.

Pearson’s AI study tools combine the power of generative AI technology with trusted Pearson content to provide scaffolded, guided help when students are stuck on homework problems, and personalized explanations, summaries, and practice problems for more efficient studying.
“Integrating AI study tools into our concept-based nursing series enhances the learning experience, giving nursing students and nurse educators the resources they need to efficiently study and master course concepts,” said Anne Fahlgren, GM of Pearson’s professional portfolio. “This technology will help more nursing candidates prepare for and enter the workforce, while also giving nurse educators the means to scale their teaching further, addressing major challenges in nursing education and society.”
The AI study tools beta will be available both in Pearson+ eTextbook and the accompanying MyLab Nursing course in time for Fall 2024. MyLab is an interactive teaching and learning platform, backed by content from Pearson authors. The platform, with integrated eTextbook, allows instructors to design their course, assign homework and assessments, and monitor student progress in real time.
The US is experiencing shortages of nurses and nurse educators. The National Academy of Medicine’s 2021 report on The Future of Nursing: 2020-2030 notes that, in order to provide sufficient care for an aging population over the next decade, a substantial increase in the nursing workforce will be needed that can practice “in community-based settings with diverse populations that face a variety of lived experiences.” The NAM’s report also references hundreds of nursing faculty position vacancies that have contributed to tens of thousands of qualified applicants being turned away from nursing school admission due to the inability to adequately meet student demand.
Concept-based nursing curriculum is designed to focus on key concepts emphasizing a holistic understanding of nursing principles that can be applied across different patient populations, healthcare settings, and situations. This approach strengthens clinical reasoning skills in the course of patient care. Incorporating generative AI tools into Pearson’s concept-based nursing content supports nurse educators in scaling their teaching and students’ ability to study more efficiently.
Dr. Michelle Aebersold, University of Michigan School of Nursing Clinical Professor and contributor to Nursing: A Concept-Based Approach to Learning, said “Technological advancements like generative AI are transforming the nursing profession. The ability to adapt in a rapidly changing environment is a critical healthcare skill, whether it’s in the course of patient care or in preparing our future nurses for the workforce. The ability of the AI study tools to provide a more user-centered, customized experience is a huge benefit for our students. I’m glad they will have access to Pearson’s AI tools that accommodate the variety of ways students learn and provide personalized support in the moment students need it most. This is the future of individualized learning.”
A Fall 2023 survey of students using Pearson’s AI study tools beta showed strong levels of engagement, with 75% of respondents saying the tools were helpful or very helpful to their studies.
The inclusion of generative AI study tools further solidifies Pearson’s dedication to providing the most comprehensive and effective learning and teaching resources for nursing students and nurse educators across the US. Pearson’s AI study tools are already available in more than 30 Pearson Mastering titles and are set to be integrated into more than 40 Pearson+ eTextbooks and MyLab and Mastering titles across math, science, business, and nursing for August of 2024.
Pearson is committed to investing in the responsible application of AI to advance product innovation and enhance the learning experience to educate, certify, and credential students and the workforce.
Pearson product experts are available to demo the AI study tools for members of the media. Please request demonstrations with the media contact below.
About Pearson
At Pearson, our purpose is simple: to add life to a lifetime of learning. We believe that every learning opportunity is a chance for a personal breakthrough. That’s why our c. 18,000 Pearson employees are committed to creating vibrant and enriching learning experiences designed for real-life impact. We are the world’s leading learning company, serving customers in nearly 200 countries with digital content, assessments, qualifications, and data. For us, learning isn’t just what we do. It’s who we are. Visit us at pearsonplc.com.
Media [email protected]
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