Regulatory affairs

X-Guide® Is The First Dental Surgical Navigation System To Receive EU MDR Certification

Retrieved on: 
Tuesday, March 5, 2024
System, MDR, Dentist, Growth, Surgeon, Regulatory affairs, University, Safety, Technical documentation, Certification, Patient, Quality management system, Quality assurance, Software, Medical device

LANSDALE, Pa., March 5, 2024 /PRNewswire/ -- X-Nav Technologies, LLC announced that the X-Guide® Dynamic 3D Surgical Navigation System is the first of its kind to receive certification under the European Union Medical Device Regulation 2017/745, commonly referred to as EU MDR.

Key Points: 
  • The regulation requires a thorough audit of a company's Technical Documentation, Clinical Evidence, and Quality Management System.
  • The completion of this process certifies that the X-Guide System delivers the claimed clinical benefits for dental surgical procedures, including dental implant surgery and endodontic access.
  • X-Guide is the industry-leading surgical navigation system used by dentists and clinicians around the world to deliver more accurate and less invasive dental surgical procedures with remarkable precision.
  • The X-Guide Surgical Navigation System is available in 23 languages and 50+ countries, holds 31 trademarks and 50+ patents, and is used by over 50 universities around the world.

Productlife Group Acquires Health Care Solution (HCS), Expanding Its Reach Across Middle East And Africa

Retrieved on: 
Tuesday, March 5, 2024
Acquisition, PLG, Quality, Regulatory affairs, Consultant, HCS

PARIS, March 5, 2024 /PRNewswire-PRWeb/ -- Health Care Solution was founded in 2016 in Casablanca, Morocco, specializing in Regulatory Affairs, Quality and Industrialization consulting. It offers operational support, audit and training services across Middle East and Africa, leveraging its strong technical and regulatory know-how. These new regional capabilities will complement PLG's end-to-end regulatory solutions designed to streamline compliance strategies across global markets.

Key Points: 
  • With this alliance, PLG reinforces its ability to support client regulatory and compliance needs globally.
  • PARIS, March 5, 2024 /PRNewswire-PRWeb/ -- Health Care Solution was founded in 2016 in Casablanca, Morocco, specializing in Regulatory Affairs, Quality and Industrialization consulting.
  • It offers operational support, audit and training services across Middle East and Africa, leveraging its strong technical and regulatory know-how.
  • The HCS consultants will be involved on larger scale global projects, and PLG will support HCS in opening new doors in Middle East and Africa.

PRODUCTLIFE GROUP ACQUIRES HEALTH CARE SOLUTION (HCS), EXPANDING ITS REACH ACROSS MIDDLE EAST AND AFRICA

Retrieved on: 
Tuesday, March 5, 2024
Acquisition, PLG, Quality, Regulatory affairs, Consultant, HCS

With this alliance, PLG reinforces its ability to support client regulatory and compliance needs globally.

Key Points: 
  • With this alliance, PLG reinforces its ability to support client regulatory and compliance needs globally.
  • Health Care Solution was founded in 2016 in Casablanca, Morocco, specializing in Regulatory Affairs, Quality and Industrialization consulting.
  • It offers operational support, audit and training services across Middle East and Africa, leveraging its strong technical and regulatory know-how.
  • The HCS consultants will be involved on larger scale global projects, and PLG will support HCS in opening new doors in Middle East and Africa.

PRODUCTLIFE GROUP ACQUIRES HEALTH CARE SOLUTION (HCS), EXPANDING ITS REACH ACROSS MIDDLE EAST AND AFRICA

Retrieved on: 
Tuesday, March 5, 2024
Acquisition, PLG, Quality, Regulatory affairs, Consultant, HCS

With this alliance, PLG reinforces its ability to support client regulatory and compliance needs globally.

Key Points: 
  • With this alliance, PLG reinforces its ability to support client regulatory and compliance needs globally.
  • Health Care Solution was founded in 2016 in Casablanca, Morocco, specializing in Regulatory Affairs, Quality and Industrialization consulting.
  • It offers operational support, audit and training services across Middle East and Africa, leveraging its strong technical and regulatory know-how.
  • The HCS consultants will be involved on larger scale global projects, and PLG will support HCS in opening new doors in Middle East and Africa.

MCRA Announces the Hiring of FDA Statistician for Diagnostic Devices

Retrieved on: 
Thursday, February 22, 2024
Computer, Senior, AI, Data monitoring committee, FDA, CDRH, Radiology, Regulatory affairs, Contract research organization, Patient, Biostatistics, Knowledge, Device, MCRA, Artificial intelligence, Medical device

WASHINGTON, Feb. 22, 2024 /PRNewswire/ -- MCRA, the leading privately held independent medical device, diagnostics, and biologics Clinical Research Organization (CRO) and advisory firm is pleased to announce the hiring of FDA Mathematical Statistician for Diagnostic Devices, Chava Zibman, Ph.D., as Principal Statistician, Diagnostics at MCRA.

Key Points: 
  • WASHINGTON, Feb. 22, 2024 /PRNewswire/ -- MCRA, the leading privately held independent medical device, diagnostics, and biologics Clinical Research Organization (CRO) and advisory firm is pleased to announce the hiring of FDA Mathematical Statistician for Diagnostic Devices, Chava Zibman, Ph.D., as Principal Statistician, Diagnostics at MCRA.
  • MCRA hires FDA Mathematical Statistician, Diagnostic Devices Chava Zibman Ph.D. as Principal Statistician, Diagnostics.
  • Dr. Zibman brings over fifteen years of statistical experience and over ten years of direct FDA experience to the position, working in the Center for Devices and Radiological Health (CDRH).
  • I am eager to help MCRA grow as the preferred consulting firm for companies seeking statistical assistance for their diagnostic devices."

Navigating the Investigational New Drug (IND) Application Process, Upcoming Webinar Hosted by Xtalks

Retrieved on: 
Thursday, February 15, 2024
FDA, Food, Drug development, IND, Doctor of Philosophy, Regulatory affairs, Risk, Pharmaceutical industry

TORONTO, Feb. 15, 2024 /PRNewswire-PRWeb/ -- Attend an informative webinar delving into the investigational new drug (IND) application process, a pivotal milestone in drug development. The IND application is an important milestone in drug development. An IND aims to demonstrate that every aspect of the drug is safe for human exposure. Sponsors need to evaluate IND readiness to ensure they have enough data to support the initiation of clinical trials. Submission of an incomplete IND lacking important studies or data can lead to a clinical hold, thus delaying clinical trials and increasing costs for the sponsor.

Key Points: 
  • In this free webinar, learn practical tips and recommendations for successfully navigating the investigational new drug (IND) application process, including actionable insights to enhance the chances of regulatory success.
  • Attendees will get an overview of the required data to support the IND opening and the initiation of clinical trials.
  • TORONTO, Feb. 15, 2024 /PRNewswire-PRWeb/ -- Attend an informative webinar delving into the investigational new drug (IND) application process, a pivotal milestone in drug development.
  • The IND application is an important milestone in drug development.

Navigating Early Cell Therapy Development: The Journey to First-in-Human Studies, Upcoming Webinar Hosted by Xtalks

Retrieved on: 
Thursday, February 15, 2024
FDA, FACMG, Innovation, Patient, Research, Cell, Regulatory affairs, Strategic management, MD, Pharmaceutical industry

TORONTO, Feb. 15, 2024 /PRNewswire-PRWeb/ -- For cell therapies, the roadmap to first-in-human studies is marked by critical scientific and regulatory milestones that require careful planning, expertise and collaboration from various stakeholders. From rigorous nonclinical studies to cell manufacturing processes to overcoming regulatory complexities, each milestone represents a significant step forward in bringing these transformative treatments to patients in need.

Key Points: 
  • In this webinar, gain insights into overarching regulatory strategies that maximize the effectiveness of interactions with the FDA and other regulatory bodies.
  • Attendees will learn about manufacturing processes to meet the demands of cell therapy clinical trials, including scalability, reproducibility and the establishment of robust quality control measures.
  • The featured speakers will share considerations for designing nonclinical studies that will lay the groundwork for first-in-human and subsequent clinical trials, drawing on real-world case studies.
  • Register for this webinar where representatives from Premier Research and Biocentriq will host a panel discussion delving into the intricacies of early cell therapy development that shape the path toward clinical trials.

Tyber Medical Acquires FDA Clearance for Proximal Tibia Plating System

Retrieved on: 
Monday, February 12, 2024
Tibia, FDA, Food, Injury, Regulatory affairs, Femur, Food and Drug Administration, Fibula, Anatomy, Trauma

BETHLEHEM, Pa., Feb. 12, 2024 /PRNewswire/ -- Tyber Medical LLC, a leading orthopedic device manufacturer providing private label orthopedic implants for the trauma, extremity, and spine markets, has received a U.S. Food and Drug Administration (FDA) 510(k) approval for its Proximal Tibia Plating System. The Tyber Medical System consists of two indication categories: Complete Articular and Partial Articular Fractures. Both designs stabilize bone fragments to facilitate highly focused and efficient healing of a wide array of injuries to the tibia, fibula, and femur. "This innovative addition to the Tyber Medical portfolio aligns to meet the needs of our customers by offering multiple solutions to challenging anatomy," commented David Hannah, Chief Technology Officer at Tyber Medical. Mr. Hannah added. "This comprehensive system offers anatomic plating to support a wide range of trauma needs."

Key Points: 
  • BETHLEHEM, Pa., Feb. 12, 2024 /PRNewswire/ -- Tyber Medical LLC, a leading orthopedic device manufacturer providing private label orthopedic implants for the trauma, extremity, and spine markets, has received a U.S. Food and Drug Administration (FDA) 510(k) approval for its Proximal Tibia Plating System.
  • The Tyber Medical System consists of two indication categories: Complete Articular and Partial Articular Fractures.
  • The Tyber Medical Proximal Tibial Plating System is engineered to accommodate surgeon preferences, increase procedural efficiency, and enhance plate fit and screw placement.
  • Lisa Boyle, Director of Regulatory Affairs commented "With the clearance of the Proximal Tibial Plating System and its sub-categories, Tyber Medical remains unwavering in our commitment to providing cutting edge orthopedic solutions."

Canoo Appoints Former NASA Chief Technology Officer Deborah Diaz and Veteran EV Transportation Leader James Chen to Board of Directors

Retrieved on: 
Wednesday, February 7, 2024
Rivian, Taft School, Regulatory affairs, United, McCaw Cellular Communications, Public policy, EVS, NASA, National Association, CIO, Science, Partner, Dana Incorporated, UNICEF, Artemis, Government, Marketing, Catalysis, Archer Aviation, Policy, ZeroAvia, Ernst & Young, United Nations, Trustee, Solera Holdings, Management

The appointments of Ms. Deborah Diaz and Mr. James Chen are effective immediately.

Key Points: 
  • The appointments of Ms. Deborah Diaz and Mr. James Chen are effective immediately.
  • “I’m excited to strengthen the board with the additions of Deborah and James,” said Tony Aquila, Investor, Executive Chairman, and CEO of Canoo.
  • Ms. Diaz currently serves on the board of directors of Archer Aviation, Primis Financial, and ZeroAvia.
  • Ms. Diaz is also Chief Executive Officer of Catalyst ADV, a technology and strategic growth advisory firm.

Shionogi Strengthens Regulatory Leadership with the Appointment of Dr. Ramón Polo as Senior Vice President, Head of Regulatory Affairs

Retrieved on: 
Monday, February 5, 2024
General Health, Health, Science, Research, Oncology, COVID-19, Senior, Management development, Head, Obesity, University of Navarra, Harvard Business School, Inc., Fragile X syndrome, Doctor of Pharmacy, Janssen Pharmaceuticals, Investment, Infection, Hepatitis C, MBA, Regulatory affairs, Master of Science, Complutense University of Madrid, RSV, Acquisition, Vaccine, University, Johnson & Johnson, Pharmaceutical industry

Shionogi Inc., a U.S. subsidiary of Shionogi & Co., Ltd. (Head Office: Osaka, Japan; President and CEO: Isao Teshirogi, Ph.D.; hereinafter “Shionogi”), announced the appointment of Ramón Polo, MBA, PharmD, Ph.D. as Senior Vice President, Head of Regulatory Affairs.

Key Points: 
  • Shionogi Inc., a U.S. subsidiary of Shionogi & Co., Ltd. (Head Office: Osaka, Japan; President and CEO: Isao Teshirogi, Ph.D.; hereinafter “Shionogi”), announced the appointment of Ramón Polo, MBA, PharmD, Ph.D. as Senior Vice President, Head of Regulatory Affairs.
  • He joins Shionogi Inc. from Johnson & Johnson, where he served as the Vice President, Head of Infectious Diseases, Vaccines & Global Public Health Regulatory Affairs.
  • Prior to this, Dr. Polo led the development strategy of treatments for influenza, RSV and hepatitis C at Janssen Pharmaceutical Companies of Johnson & Johnson.
  • Dr. Polo received his PharmD, Master of Science and Ph.D. in Clinical Biochemistry from the Complutense University of Madrid in Spain.