Competent authority

An Introduction to the Medical Device Regulation Training Course: In-Depth Insight Into the European MDR Legislation - ResearchAndMarkets.com

Retrieved on: 
Wednesday, April 19, 2023
Medical Devices, Health, CE, Medicine, BSI, Medical device, QMS, Classification, Marketing, ISO, Pharmaceuticals and Medical Devices Agency, Writing, European Medicines Agency, UK Notified Bodies, Medication, Notified body, Technical director, Research, European Medical Devices Industry Group, Bachelor of Science, NextGen Healthcare, EMA, MHRA, European, Certification, ISO 13485, Pharmacy, R, Competent authority, Speech-generating device, Test management, Clinical, LRQA, Pharmacist, Nursing, Management

She has extensive experience of conducting clinical studies with medical device products as well as regulatory expertise for CE marking of devices.

Key Points: 
  • She has extensive experience of conducting clinical studies with medical device products as well as regulatory expertise for CE marking of devices.
  • Specifically she has been involved in writing and reviewing hundreds of Clinical evaluation reports for the medical device industry, she ahs also provided training to Notified bodies in this subject.
  • Janette sits on several committees in the device community and industry and has been an instrumental advocate of improving and advancing medical device research in the UK.
  • Her first introduction to the Medical device Industry was as the R&D Manager for a medical device manufacturer, with responsibility for the development of several device drug combination products, with the core technology utilizing bovine collagen.

EBA updates list of CET1 instruments

Retrieved on: 
Monday, January 16, 2023
Commission, Competent authority, CRR, Article, Review, Capital Requirements Regulation 2013, EBA, Authority, Urban economics, Joint committee, Common equity, EEA, Union, European Banking Authority, European Economic Area, Article 29 Data Protection Working Party, European, Security (finance), EU

Since the publication of the last updated list of CET1 capital instruments on 8 December 2021, the EBA has continued monitoring and assessing the capital instruments issued by EU institutions and their eligibility towards the criteria set in the CRR.

Key Points: 
  • Since the publication of the last updated list of CET1 capital instruments on 8 December 2021, the EBA has continued monitoring and assessing the capital instruments issued by EU institutions and their eligibility towards the criteria set in the CRR.
  • Following the Joint Committee EEA Decision adopting the CRR1 that entered into force on 1 January 2020, the EBA assessed all types of CET1 instruments issued in the EEA counties in order to add them to the CET1 list.
  • Given that all instruments were considered as fully compliant with the eligibility criteria set out in the CRR, the instruments are now included in the updated CET1 list and new highlighted rows have been added to flag these instruments.
  • In particular, the CRR2 provides for the EBA to be consulted ex ante for new forms of instruments that are not yet included in the CET1 list in order for them to be classified as CET1 instruments.

Vega Therapeutics launches and unveils its first-in-class antibody therapy for von Willebrand disease at ASH Annual Meeting

Retrieved on: 
Tuesday, December 6, 2022
Science, Biotechnology, Research, Pharmaceutical, Health, Genetics, Clinical Trials, Other Health, Therapy, Norwest Venture Partners, RA, SC, Clinical trial, MD, Haemophilia, Coagulation, Doctor of Philosophy, Competent authority, Society, Patient, Entrepreneurship, Thrombin, Biology, Vega, APC, Coagulopathy, Von Willebrand factor, Bleeding, VWF, VWD, Trial of the century, Von Willebrand disease, Fibrinolysis, Degenerative disease, Pharmacokinetics, Blood, ASH, Protein S, Pharmaceutical industry

Vega was spun out of its parent company, Star Therapeutics , to advance the discovery and development of antibody therapies for patients with blood disorders, starting with von Willebrand disease (VWD).

Key Points: 
  • Vega was spun out of its parent company, Star Therapeutics , to advance the discovery and development of antibody therapies for patients with blood disorders, starting with von Willebrand disease (VWD).
  • Vega will disclose the first public information about VGA039 in a podium presentation on December 12th at the ASH Annual Meeting in New Orleans.
  • In VWD, defective or low amounts of von Willebrand factor (VWF) leads to insufficient platelet adhesion and unstable clot formation.
  • Vega Therapeutics is a clinical stage biotechnology company developing novel, first-in-class therapies for rare blood disorders with overlooked patient needs, starting with von Willebrand disease (VWD).

EBA publishes methodology and draft templates for the 2023 EU-wide stress test

Retrieved on: 
Wednesday, November 9, 2022
Central bank, CAS, EBA, Industry, EC, Income, Royal commission, European Banking Authority, ESRB, European, European Central Bank, ECB, European Systemic Risk Board, Competent authority, European Commission, Exercise, Risk management, Medical device, EU

04 November 2022

Key Points: 
  • 04 November 2022
    The European Banking Authority (EBA) published today the final methodology, draft templates and template guidance for the 2023 EU-wide stress test along with the milestone dates for the exercise.
  • The stress test exercise will be launched in January 2023 with the publication of the macroeconomic scenarios.
  • The 2023 EU-wide stress test uses a constrained bottom-up approach with some top-down elements.
  • The EBA EU-wide stress test is conducted in a bottom-up fashion, using consistent methodologies, scenarios and key assumptions developed jointly with other authorities.

Equiduct launches trading of the Nordic markets on Apex

Retrieved on: 
Wednesday, November 9, 2022
Competence, Competent authority, ADV, Best execution, Berlin, Directive 2014/65/EU, Nasdaq, COVID-19, BBO, ETF, Financial adviser, Nordic, Apex, Börse Berlin

LONDON, Nov. 9, 2022 /PRNewswire/ -- Equiduct, the pan-European retail exchange, announced today that it has launched the Nordic markets on Apex, Equiduct's commission-free, Best Execution service for retail orders. More than five million retail investors connected to Apex through their retail brokers now have access to 208 Swedish, Norwegian, Danish and Finnish stocks.

Key Points: 
  • LONDON, Nov. 9, 2022 /PRNewswire/ -- Equiduct, the pan-European retail exchange, announced today that it has launched the Nordic markets on Apex, Equiduct's commission-free, Best Execution service for retail orders.
  • The Apex service for the Nordic region is supported by a pool of liquidity providers who are committed to deliver additional retail-specific liquidity in the Equiduct order book.
  • Josephson, who will be covering all Nordic markets from Stockholm, joins Equiduct from Infront ASA, where he worked as Sales Director for almost eight years.
  • [1] Source: Nasdaq, 26 September 2022, "4 Takeaways From Recent Retail Activity in Nordic & Baltic Markets" Report, available: https://www.nasdaq.com/docs/2022/09/27/4-Key-Takeaways-from-Recent-Retai...

Equiduct launches trading of the Nordic markets on Apex

Retrieved on: 
Wednesday, November 9, 2022
Competence, Competent authority, ADV, Best execution, Berlin, Directive 2014/65/EU, Nasdaq, COVID-19, BBO, ETF, Financial adviser, Nordic, Apex, Börse Berlin

LONDON, Nov. 9, 2022 /PRNewswire/ -- Equiduct, the pan-European retail exchange, announced today that it has launched the Nordic markets on Apex, Equiduct's commission-free, Best Execution service for retail orders. More than five million retail investors connected to Apex through their retail brokers now have access to 208 Swedish, Norwegian, Danish and Finnish stocks.

Key Points: 
  • LONDON, Nov. 9, 2022 /PRNewswire/ -- Equiduct, the pan-European retail exchange, announced today that it has launched the Nordic markets on Apex, Equiduct's commission-free, Best Execution service for retail orders.
  • The Apex service for the Nordic region is supported by a pool of liquidity providers who are committed to deliver additional retail-specific liquidity in the Equiduct order book.
  • Josephson, who will be covering all Nordic markets from Stockholm, joins Equiduct from Infront ASA, where he worked as Sales Director for almost eight years.
  • [1] Source: Nasdaq, 26 September 2022, "4 Takeaways From Recent Retail Activity in Nordic & Baltic Markets" Report, available: https://www.nasdaq.com/docs/2022/09/27/4-Key-Takeaways-from-Recent-Retai...

Greenberg Traurig's Global Tax Practice Adds Sharon Katz-Pearlman, a Marquee Name in Tax Controversy Practice

Retrieved on: 
Tuesday, September 20, 2022
IRS, KPMG, Center for Resource Solutions, AM, MAP, Efficiency, New York University School of Law, Center, Legislation, Controversy, United Nations Committee on the Peaceful Uses of Outer Space, United States Department of the Treasury, Co-managed Security, Treasury, Compliance, University School, Program, Environment, APA, LLP, NLJ, Lawsuit, Competence, Competent authority, International, Multilateralism, Accounting, Insurance

NEW YORK, Sept. 19, 2022 /PRNewswire-PRWeb/ -- Transfer Pricing and Competent Authority Experience Complement Firm's Global Tax Practice

Key Points: 
  • KPMG International's Global Head of Tax Dispute Resolution & Controversy and the Co-Principal in Charge of KPMG LLP's U.S. Tax Dispute Resolution Practice, Sharon Katz-Pearlman, joined Greenberg Traurig's Global Tax Practice.
  • KPMG International's Global Head of Tax Dispute Resolution & Controversy and the Co-Principal in Charge of KPMG LLP's U.S. Tax Dispute Resolution Practice, Sharon Katz-Pearlman , joined Greenberg Traurig's Global Tax Practice .
  • Katz-Pearlman's addition expands Greenberg Traurig's highly regarded global tax team with her experience in transfer pricing, and Competent Authority proceedings, including MAP and APA matters.
  • Greenberg Traurig's multidisciplinary tax team works closely with clients to address these and other tax planning needs, as well as tax controversies and litigation issues.

An Introduction to the Medical Device Regulation Training Course: London, United Kingdom - August 1-3, 2022

Retrieved on: 
Friday, July 29, 2022
ISO, Medication, R, Pharmacist, Pharmaceuticals and Medical Devices Agency, Clinical, MHRA, Industry, Medicine, European Medical Devices Industry Group, Notified body, European, ISO 13485, Bachelor of Science, Research, NextGen Healthcare, EMA, Non-functional testing, Marketing, Classification, Pharmacy, CE, Solution, UK Notified Bodies, Speech-generating device, QMS, European Medicines Agency, BSI, LRQA, Medical device, Competent authority, Department, Technical director, Certification, Writing, Management

She has extensive experience of conducting clinical studies with medical device products as well as regulatory expertise for CE marking of devices.

Key Points: 
  • She has extensive experience of conducting clinical studies with medical device products as well as regulatory expertise for CE marking of devices.
  • Specifically she has been involved in writing and reviewing hundreds of Clinical evaluation reports for the medical device industry, she ahs also provided training to Notified bodies in this subject.
  • Janette sits on several committees in the device community and industry and has been an instrumental advocate of improving and advancing medical device research in the UK.
  • Her first introduction to the Medical device Industry was as the R&D Manager for a medical device manufacturer, with responsibility for the development of several device drug combination products, with the core technology utilizing bovine collagen.

An Introduction to the Medical Device Regulation Training Course: London, United Kingdom - August 1-3, 2022 - ResearchAndMarkets.com

Retrieved on: 
Tuesday, July 26, 2022
Medical Devices, Health, ISO, Medication, R, Pharmacist, Pharmaceuticals and Medical Devices Agency, Clinical, MHRA, Industry, Medicine, European Medical Devices Industry Group, Notified body, European, ISO 13485, Bachelor of Science, Research, NextGen Healthcare, EMA, Non-functional testing, Marketing, Classification, Pharmacy, CE, Solution, UK Notified Bodies, Speech-generating device, QMS, European Medicines Agency, BSI, LRQA, Medical device, Competent authority, Department, Technical director, Certification, Writing, Management

She has extensive experience of conducting clinical studies with medical device products as well as regulatory expertise for CE marking of devices.

Key Points: 
  • She has extensive experience of conducting clinical studies with medical device products as well as regulatory expertise for CE marking of devices.
  • Specifically she has been involved in writing and reviewing hundreds of Clinical evaluation reports for the medical device industry, she ahs also provided training to Notified bodies in this subject.
  • Janette sits on several committees in the device community and industry and has been an instrumental advocate of improving and advancing medical device research in the UK.
  • Her first introduction to the Medical device Industry was as the R&D Manager for a medical device manufacturer, with responsibility for the development of several device drug combination products, with the core technology utilizing bovine collagen.

New EU Medical Devices Regulations Training: Two Day Virtual Seminar - Essential Tasks to Complete the EU MDR Implementation and Transition (October 12-13, 2022) - ResearchAndMarkets.com

Retrieved on: 
Monday, May 30, 2022
Medical Devices, Health, European Commission, Patient, Competent authority, MDCG, Uncertainty, View, EU MDR, New, Legislation, CAS, IVDR, MDR, Transition, Medical device, EU

The "The New EU Medical Devices Regulations Training - Essential Tasks to Complete the EU MDR Implementation and Transition" training has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "The New EU Medical Devices Regulations Training - Essential Tasks to Complete the EU MDR Implementation and Transition" training has been added to ResearchAndMarkets.com's offering.
  • This 2-day virtual seminar will go into the specifics of the European Union Medical Device Regulation (EU MDR), provide case studies and share lessons learned so your organization can benefit from the mistakes of others.
  • We will review the latest changes to the regulations effective and in force and will draw out key developments and key dates.
  • The new EU Medical Devices Regulations (the MDR and IVDR) for medical devices and 2022 (for in vitro diagnostic medical devices).