Journalist

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

Retrieved on: 
Tuesday, March 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.

FEMME! 2024 Power Confab & Retreat to Feature a Women’s History Month Conversation With Acclaimed Journalist, Bestselling Author & Former First Lady of California, Maria Shriver

Retrieved on: 
Monday, February 26, 2024

2024 Power Confab & Retreat, presented by AARP, Comcast NBCUniversal Telemundo, and INGEÑUITY.

Key Points: 
  • 2024 Power Confab & Retreat, presented by AARP, Comcast NBCUniversal Telemundo, and INGEÑUITY.
  • 2024 will Celebrate + Illuminate + Elevate at a two-day Power Confab & Retreat designed to stimulate the senses, fuel creativity, foster mentoring and empower women!
  • 2024 is a gathering of more than 300 multicultural sheroes, disruptors, changemakers, thought-leaders, visionaries and power brokers.
  • 2024 featured guests include acclaimed Journalist, New York Times #1 Bestselling Author, Entrepreneur, Former First Lady of California, and Founder of Shriver Media, Maria Shriver.

SHE Media's Second Annual Co-Lab at SXSW® Elevating Leading Voices in Women's Health to the Mainstage

Retrieved on: 
Friday, March 8, 2024

AUSTIN, Texas, March 8, 2024 /PRNewswire/ -- Today, SHE Media, a mission-driven media company, announced its full agenda and latest speaker lineup for the Co-Lab: Whole Life Health at South by Southwest® (SXSW®). The highly anticipated activation, in its second year, will take place March 9, 10 and 11 in Downtown Austin at 206 E 4th St. Attendees will hear from experts, advocates, and thought leaders as they share both the science and stories of women's whole life health including the latest innovations and how technology is revolutionizing healthcare. Doors will open daily at 9am and close at 5pm with panel discussions and fireside chats programmed throughout the day. Full agenda details and updates can be found here.

Key Points: 
  • Doors will open daily at 9am and close at 5pm with panel discussions and fireside chats programmed throughout the day.
  • The Co-Lab at SXSW marks the one-year anniversary of launching Flow Space , SHE Media's proprietary digital and live media platform providing content, community, and commerce in service of women's health.
  • Learn how we can better care for our hearts, including how symptoms differ in women, preventative measures and innovations that can reduce risk.
  • plusOne® Sexual Wellness in Full Bloom | Attendees can celebrate sexual wellness by stopping by the plusOne® flower cart to receive a tote and Rose Arouser.

Fortune Names Maryam Banikarim to Lead Its Most Powerful Women and Brainstorm Tech Franchises

Retrieved on: 
Thursday, March 7, 2024

NEW YORK, March 7, 2024 /PRNewswire/ -- Fortune Media announced today the appointment of Maryam Banikarim as Managing Director, Fortune Live Media.

Key Points: 
  • NEW YORK, March 7, 2024 /PRNewswire/ -- Fortune Media announced today the appointment of Maryam Banikarim as Managing Director, Fortune Live Media.
  • Banikarim will be responsible for the media company's prestigious Most Powerful Women (MPW) and Brainstorm Tech global franchises.
  • I couldn't be more excited to work with the talented group of journalists and professionals at Fortune to grow the Most Powerful Women and Brainstorm Tech franchises," said Banikarim.
  • Banikarim joins Fortune after being a guest co-chair of the 2023 Fortune Most Powerful Women summit and as a longtime member of the MPW community.

ANNOUNCING ENVESTNET ELEVATE 2024 - THE WEALTH INDUSTRY'S PREMIER EVENT SHOWCASING ENVESTNET'S INDUSTRY-LEADING, CONNECTED ECOSYSTEM POWERING GROWTH FOR 108,000 ADVISORS

Retrieved on: 
Monday, March 4, 2024

BERWYN, Pa., March 4, 2024 /PRNewswire/ -- Envestnet's industry-leading Wealth Management Platform will take center stage as Envestnet welcomes 3,000 financial advisors and financial professionals to its annual industry conference – Envestnet Elevate 2024, to be held May 14-15 at the Phoenix Convention Center in Phoenix, AZ. Celebrating its 25th anniversary this year, Envestnet has chosen a theme for the two-day event that resonates deeply with wealth management professionals: "Connection."

Key Points: 
  • Celebrating its 25th anniversary this year, Envestnet has chosen a theme for the two-day event that resonates deeply with wealth management professionals: "Connection."
  • "Our focus this year at Envestnet Elevate 2024 is to demonstrate and showcase the power of our fully connected wealth management platform – and celebrate what connects us.
  • "At Elevate 2024, helping advisors leverage the Envestnet ecosystem for business growth is front and center.
  • The future of connected financial advice is on display at Envestnet Elevate this May – don't miss out.

WOMEN RAISE THE GAME TAKES CENTER STAGE DURING SUPER BOWL WEEKEND HONORING DYNAMIC WOMEN BEHIND THE SCENES IN SPORTS

Retrieved on: 
Friday, February 16, 2024

LAS VEGAS, Feb. 16, 2024 /PRNewswire/ -- Women Raise the Game, Presented by Boldyn Networks, hosted a memorable honoree experience during Super Bowl weekend recognizing a group of extraordinary women who play pivotal roles behind the scenes in sports.

Key Points: 
  • LAS VEGAS, Feb. 16, 2024 /PRNewswire/ -- Women Raise the Game, Presented by Boldyn Networks, hosted a memorable honoree experience during Super Bowl weekend recognizing a group of extraordinary women who play pivotal roles behind the scenes in sports.
  • Other notable guests included Grammy Award winning Producer Hit-boy, Actively Black CEO Lanny Smith, and Tech Entrepreneur & Diversity Advocate Marilyn Booker.
  • With heartfelt speeches and tokens of appreciation, these athletes expressed gratitude for the unwavering encouragement, support, and sacrifices made by these dynamic women.
  • Zaileen Janmohamed, President & CEO of the Bay Area Host Committee who received the Woman of the Year Award said, "Women really do raise the game.

THE NEWS FORUM building news and content coalitions across Canada

Retrieved on: 
Wednesday, February 14, 2024

FORUM DAILY WEST, is a daily news program focusing on Western Canada stories, launching February 26, 2024 (Monday to Friday 11PM ET).

Key Points: 
  • FORUM DAILY WEST, is a daily news program focusing on Western Canada stories, launching February 26, 2024 (Monday to Friday 11PM ET).
  • The News Forum presents BREAK THE NEEDLE, a 44-minute weekly show hosted by Adam Zivo, to find answers.
  • DOCUMENTARIES - The News Forum has also partnered with Serendipity Media Production, to broadcast a wide range of Canadian productions.
  • "I am thrilled and energized by the incredible synergy that our distribution partnerships with The News Forum bring to our content.

GENESIS AND THE COUNCIL OF FASHION DESIGNERS OF AMERICA ANNOUNCE FIRST DESIGN + INNOVATION GRANT WINNER

Retrieved on: 
Thursday, February 8, 2024

NEW YORK, Feb. 8, 2024 /PRNewswire/ -- Genesis and the Council of Fashion Designers of America (CFDA) are pleased to announce the first ever CFDA | Genesis House AAPI Design + Innovation Grant winner, Grace Ling.

Key Points: 
  • NEW YORK, Feb. 8, 2024 /PRNewswire/ -- Genesis and the Council of Fashion Designers of America (CFDA) are pleased to announce the first ever CFDA | Genesis House AAPI Design + Innovation Grant winner, Grace Ling.
  • CFDA | Genesis House AAPI Design + Innovation Grant winner, Grace Ling, produced a collection of three full looks inspired by a femme fatale character, each representing seduction, transformation and initiation.
  • "I am very honored to be the recipient of Genesis House's first AAPI Innovation Grant with CFDA," said Grace Ling, designer.
  • Genesis designs customer experiences that go beyond products, embodying audacious, forward-thinking, and distinctly Korean characteristics within its unique Athletic Elegance design identity.

Raiders' Head Coach, Antonio Pierce to be awarded Leader of the Year at Andre Farr Million Dollar Dinner presented by Executive Member Group during Big Game Weekend

Retrieved on: 
Friday, February 2, 2024

In keeping with an unswerving standard of excellence, this event is curated specifically for influential leaders in sports, entertainment, and business.

Key Points: 
  • In keeping with an unswerving standard of excellence, this event is curated specifically for influential leaders in sports, entertainment, and business.
  • "I am honored to annually host dynamic and accomplished Black leaders of the global intersection of sports, entertainment, and business.
  • In addition to Antonio Pierce receiving the Leader of the Year Award, Vada O.
  • – Larry Miller, Chairman, Jordan Brand Advisory Board
    "The Super Bowl Executive Dinner is literally the tide that lifts culture and community.

Managing burnout and stress as a journalist: Free webinar, Jan. 12

Retrieved on: 
Tuesday, January 2, 2024

Research shows these stressors affect journalists' mental health.

Key Points: 
  • Research shows these stressors affect journalists' mental health.
  • Join the National Press Club Journalism Institute at 11:30 am ET on Friday, Jan. 12, for a conversation focused on practical tips and effective methods for journalists and newsroom leaders to address stress and burnout.
  • Registration is open for this free webinar.
  • Tara Francis Chan , managing editor & operations director, The Appeal
    Naseem Miller , senior editor for health, The Journalist's Resource
    AX Mina , senior civic media fellow, USC Annenberg School of Journalism
    Samantha Ragland , vice president, journalism programs, American Press Institute