MRP

ICH E2D(R1) Guideline on post-approval safety data Step 2b - Revision 1

Retrieved on: 
星期二, 三月 12, 2024

The completed comments form should be sent to

Key Points: 
    • The completed comments form should be sent to
      [email protected]
      *For more information please refer to Public consultation explanatory note: Proposed E2B(R3) updates
      to align with ICH E2D(R1) guideline.
    • 18
      July 2003

      E2D

      Approval by the Steering Committee under Step 4 and
      recommendation for adoption to the three ICH
      regulatory bodies.

    • 12
      November 2003

      New
      Codification
      November
      2005
      E2D

      E2D

      Revision of E2D
      Code

      History

      E2D(R1) Endorsement by the Members of the ICH Assembly
      under Step 2 and release for public consultation.

    • Date

      New
      Codification

      5 February 2024

      E2D(R1)

      POST-APPROVAL SAFETY DATA:
      DEFINITIONS AND STANDARDS FOR MANAGEMENT AND
      REPORTING OF INDIVIDUAL CASE SAFETY REPORTS
      E2D(R1)
      ICH Consensus Guideline
      Table of Contents
      1.

    • The ICH E2D guideline provides guidance on definitions and standards for post-

      5

      approval individual case safety reporting, as well as good case management practices.

    • Detailed guidance on the

      9

      specific structure, format, standards, and data elements for transmitting Individual Case Safety

      10

      Reports (ICSRs) is provided in the ICH E2B guideline.

    • Guidance on periodic reporting of

      11

      aggregated safety data is covered in the ICH E2C guideline.

    • 12

      This guideline provides recommendations that are harmonised to the extent possible given

      13

      differences in post-market safety reporting requirements among ICH regions.

    • 25

      2.1.2

      Adverse Drug Reaction (ADR)

      26

      Adverse drug reactions, as defined by local and regional requirements, concern noxious and

      27

      unintended responses to a medicinal product.

    • 66

      Product labelling may include information related to ADRs for the pharmaceutical class to

      67

      which the medicinal product belongs.

    • In some cases, ?other observations? can occur

      78

      without any associated AEs/ADRs, while in other cases ?other observations? can occur with

      79

      an associated AE/ADR.

    • 84

      For the purpose of reporting, requirements in some regions refer only to ADRs, whereas other

      85

      regions refer to AEs.

    • 86

      Refer to local and regional requirements for specifications and requirements on the reporting

      87

      of AEs or ADRs to each Regulatory Authority.

    • 89

      2.2

      90

      An ICSR is a description of an AE/ADR or other observation in an individual patient at a specific

      91

      point of time.

    • Cases missing any of the above criteria do not qualify for reporting; due diligence

      99

      should be exercised to collect the missing criteria.

    • 6

      104

      An ICSR can be a description of at least one AE/ADR, or other observation (see Section 5.1.3,

      105

      Other Observations), or both.

    • Primary sources, often referred

      112

      to as ?reporters?, include healthcare professionals and consumers who provide facts about a case

      113

      to the MAH or regulatory authority.

    • 127

      2.7

      128

      A digital platform is the software and technology used to enable transmission of information

      129

      between users (see Section 4.3, Digital Platforms).

    • Expedited Report

      Primary Source

      Healthcare Professional (HCP)

      Consumer

      Digital Platform

      7

      130

      2.8

      131

      An organised data collection system (ODCS) is an activity that gathers data in a planned manner,

      132

      thereby enabling review to be performed.

    • MAHs should also follow the

      286

      advice in Section 5.1.2, Important Safety Findings, about communicating safety findings to

      13

      287

      regulatory authorities.

    • MAHs may conduct an MRP

      395

      using a digital platform; in this situation the ICH E2B data element value for ?MRP? should be

      396

      selected.

    • 564

      Terms (e.g., AEs/ADRs, indication, and medical conditions) in the narrative should be accurately

      565

      reflected in appropriate ICH E2B data elements.

    • 638

      Regulatory Authorities and MAHs should consider and manage duplicates when reviewing

      639

      pharmacovigilance data, as duplicates negatively impact signal detection.

    • 651

      Duplicate detection relies on good quality data and is generally based on similarities but should

      652

      take into account that information in ICSRs may differ between reporters.

MRP Strengthens Market Reach and Global Scale in B2B Data Through Strategic Combination with CONTENTgine, a Pioneer in First-Party Audience Engagement and Demand Generation

Retrieved on: 
星期五, 三月 1, 2024

This combination will establish MRP as an end-to-end provider that covers the entire B2B technology sales and marketing process.

Key Points: 
  • This combination will establish MRP as an end-to-end provider that covers the entire B2B technology sales and marketing process.
  • This includes demand generation across all stages of the buyer's journey, integrated multi-channel solutions, proprietary first-party down-funnel intent buying signals, and sales pipeline activations.
  • This engine will gather millions of B2B audience interactions to generate detailed signals at the location level for optimal and timely campaign targeting.
  • Comprehensive Global Audience Reach: MRP and CONTENTgine’s combined global audiences now provide greater scale across North America, LATAM, EMEA, and APAC markets with a combined reach of 270m+ contacts across 25m+ companies.

Exelon Reports Fourth Quarter and Full Year 2023 Results and Initiates 2024 Financial Outlook

Retrieved on: 
星期三, 二月 21, 2024

Exelon Corporation (Nasdaq: EXC) today reported its financial results for the fourth quarter and full year 2023.

Key Points: 
  • Exelon Corporation (Nasdaq: EXC) today reported its financial results for the fourth quarter and full year 2023.
  • Adjusted (non-GAAP) Operating Earnings for the fourth quarter of 2023 increased to $0.60 per share from $0.43 per share in the fourth quarter of 2022.
  • ComEd's fourth quarter of 2023 GAAP Net Income increased to $268 million from $211 million in the fourth quarter of 2022.
  • PHI’s fourth quarter of 2023 GAAP Net Income increased to $101 million from $90 million in the fourth quarter of 2022.

Questions and answers on the European Union framework for (traditional) herbal medicinal products, including those from a ‘non-European’ tradition

Retrieved on: 
星期日, 三月 10, 2024

1

Key Points: 
    • 1
      Committee on Herbal Medicinal Products (HMPC)

      Questions & Answers on the European Union framework
      for (traditional) herbal medicinal products, including those
      from a ?non-European? tradition

      Table of Content
      1.

    • European Pharmacopoeia

      SAWP

      Scientific Advice Working Party

      SmPC

      Summary of Product Characteristics

      THMP

      Traditional Herbal Medicinal Product

      TUR

      Traditional Use Registration

      WEU

      Well-Established Use

      Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.

    • Terminology of herbal medicinal products (Q&A 1-4)

      Question 1
      What are herbal substances, herbal preparations, and herbal medicinal products?

    • Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.
    • Question 4
      Are food supplements regulated under the European Union (EU) pharmaceutical legislation
      for (traditional) herbal medicinal products ((T)HMPs)?
    • Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.
    • Regulation of herbal medicinal products in the European Union (Q&A 511)

      Question 5
      Where to find the pharmaceutical legislation and dossier requirements for herbal medicinal
      products (HMPs), including traditional herbal medicinal products (THMPs), in the European
      Union (EU)?

    • Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.
    • These countries have,
      through the EEA agreement, adopted the complete Union acquis on medicinal products and are
      consequently parties to the Union procedures.
    • Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.
    • Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.
    • Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.
    • Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.
    • Specific provisions for traditional herbal medicinal products (Q&A 1221)

      Question 12
      Which indications can be granted for traditional herbal medicinal products (THMPs)?

    • Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.
    • Nov. 2023
      Answer 17

      Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.

    • Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.
    • Question 29
      Does the Committee on Herbal Medicinal Products (HMPC) hold a specific database on
      (registered) authorised (traditional) herbal medicinal products ((T)HMPs)?
    • Discussion with Member States intended to be

      Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.

    • Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.

Huawei Announces Flash Forward Action Plan to Help Enterprises Address Data Challenges in the Intelligent Era

Retrieved on: 
星期二, 三月 5, 2024

BARCELONA, Spain, March 5, 2024 /PRNewswire/ -- At MWC Barcelona 2024, Huawei unveiled its Flash Forward action plan, which promotes actions related to three key areas, namely, all flash for all scenarios, greenness and sustainability, and data resilience and reliability, to help enterprises address various data challenges in the intelligent era.

Key Points: 
  • BARCELONA, Spain, March 5, 2024 /PRNewswire/ -- At MWC Barcelona 2024, Huawei unveiled its Flash Forward action plan, which promotes actions related to three key areas, namely, all flash for all scenarios, greenness and sustainability, and data resilience and reliability, to help enterprises address various data challenges in the intelligent era.
  • Thanks to its high performance, low power consumption, and high reliability, flash storage is now widely used in multiple core-enterprise-application scenarios.
  • According to Gartner, the global all-flash storage market will account for more than 90% of the storage market by 2026.
  • Michael Qiu, President of Huawei Global Data Storage Marketing & Solution Sales, said, "We hope to inspire customers in various industries to build an efficient, green, resilient, and reliable data infrastructure through our actions related to Flash Forward action plan.

MWC 2024 | Huawei Multilayer Ransomware Protection (MRP) Solution Becomes the First to Get Tolly-certified

Retrieved on: 
星期三, 二月 28, 2024

BARCELONA, Spain, Feb. 28, 2024 /PRNewswire/ -- At MWC Barcelona 2024, Huawei's Multilayer Ransomware Protection (MRP) Solution was certified by Tolly Group, an authoritative international testing organization.

Key Points: 
  • BARCELONA, Spain, Feb. 28, 2024 /PRNewswire/ -- At MWC Barcelona 2024, Huawei's Multilayer Ransomware Protection (MRP) Solution was certified by Tolly Group, an authoritative international testing organization.
  • Huawei MRP solution is the first ransomware protection solution in the industry to achieve network-storage collaboration, and provides a two-line defense that includes six-layers of protection.
  • The storage is the last line of defense for data protection, providing storage protection, secure snapshot, backup protection, and isolation zone protection.
  • At MWC 2024, Kevin Tolly, founder of the Tolly Group, issued the "Huawei Multilayer Ransomware Protection (MRP) Solution" certificate to Huawei.

Huawei Launches Ten Industrial Digital and Intelligent Transformation Solutions, and a Series of New Flagship Products

Retrieved on: 
星期三, 二月 28, 2024

BARCELONA, Spain, Feb. 28, 2024 /PRNewswire/ -- During the MWC Barcelona 2024, Huawei hosted the Huawei Industrial Digital and Intelligent Transformation Summit.

Key Points: 
  • BARCELONA, Spain, Feb. 28, 2024 /PRNewswire/ -- During the MWC Barcelona 2024, Huawei hosted the Huawei Industrial Digital and Intelligent Transformation Summit.
  • Huawei launched ten industrial digital and intelligent transformation solutions, and a series of new flagship products, to meet the needs of customers at different stages of industrial transformation.
  • Huawei will double our efforts to offer more intelligent digital infrastructure products and solutions that accelerate the intelligent transformation of industries.
  • As digital and intelligent transformation continues to progress, Huawei is dedicated to developing scenario-based, cutting-edge, green, and low-carbon products and solutions to meet customer needs."

Powered by MRP Announces Attendance at the 2024 AAD Annual Meeting in San Diego Mar. 8th-10th

Retrieved on: 
星期四, 二月 22, 2024

PARK CITY, Utah, Feb. 22, 2024 /PRNewswire/ -- Powered by MRP , the globally recognized marketplace for energy-based medical devices, is pleased to announce their attendance at the upcoming 2024 AAD Annual Meeting held at the San Diego Convention Center on March 8th-10th.

Key Points: 
  • PARK CITY, Utah, Feb. 22, 2024 /PRNewswire/ -- Powered by MRP , the globally recognized marketplace for energy-based medical devices, is pleased to announce their attendance at the upcoming 2024 AAD Annual Meeting held at the San Diego Convention Center on March 8th-10th.
  • The American Academy of Dermatology, founded in 1938, is the largest, most influential and most representative group of dermatologists in the US.
  • With over 350 exhibiting companies and 8,000 medical personnel, the 2024 AAD Annual Meeting features presentations, exhibits, and networking opportunities for dermatologists, researchers, and industry professionals to discuss the latest developments in dermatology research, clinical practice, and education.
  • This includes leading aesthetics laser companies, for which MRP is the exclusive distributor, such as Luvo, Jeisys and Bluecore.

Gus Fonte Elected to Lead Nation's Largest Local Realtor Association

Retrieved on: 
星期五, 二月 2, 2024

MIAMI, Feb. 2, 2024 /PRNewswire-PRWeb/ -- The MIAMI Association of Realtors (MIAMI) installed 2024 MIAMI Chairman of the Board Gus Fonte, CCIM at its Inaugural & Awards Celebration on Feb. 2 at the Seminole Hard Rock Hotel & Casino in Hollywood.

Key Points: 
  • "As a proud MIAMI member since 1987, I'm honored to lead our incredible association, the largest in the United States"
    "As a proud MIAMI member since 1987, I'm honored to lead our incredible association, the largest in the United States," Fonte said.
  • Let's showcase our Realtor value proposition, continue our industry-leading advocacy efforts and elevate our Realtor education.
  • Fonte has volunteered his time as a MIAMI Association of Realtors leader since 2005, when he led MIAMI Commercial.
  • Born and raised in Miami, Fonte currently lives in Miami with his wife, Maryellen, and has two children, Gus and Mia.

Acumatica Cloud ERP Previews Advanced Product Features During Day 2 of Summit 2024

Retrieved on: 
星期二, 一月 30, 2024

LAS VEGAS, Jan. 30, 2024 /PRNewswire/ -- Acumatica, an industry-leading business solutions provider, today highlighted current capabilities enabling mid-market businesses to grow, scale and drive efficiencies. The company previewed new features and capabilities that will launch in the 2024 R1 product release – with the beta of 2024 R1 available today to Acumatica customers.

Key Points: 
  • The company previewed new features and capabilities that will launch in the 2024 R1 product release – with the beta of 2024 R1 available today to Acumatica customers.
  • "Our bet is on our customers, which is why we heavily weight our product roadmap in favor of their input," said Ali Jani, chief product officer at Acumatica.
  • "Our product managers visit customers throughout the year and use takeaways from these discussions to innovate our solutions.
  • Both the Day 1 and Day 2 Keynotes highlighted the need for better ways to approach business data and decision-making.