Seriousness

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.

AnxietyChecklist.com Launches: Revolutionizing Anxiety Management Online

Retrieved on: 
Thursday, February 1, 2024

DUBAI, UAE, Feb. 1, 2024 /PRNewswire-PRWeb/ -- In a world increasingly aware of mental health challenges, AnxietyChecklist.com stands as a pioneering online resource, specifically addressing the complexities of anxiety disorders and panic attacks. This innovative platform not only sheds light on the prevalence and impacts of these conditions but also offers concrete, research-backed solutions.

Key Points: 
  • Discover the innovative approach to beat anxiety with the launch of AnxietyChecklist.com, your new online destination for practical anxiety management tools and resources.
  • Our mission is to demystify anxiety management and provide accessible, effective tools for everyone."
  • - Romain Brabant
    AnxietyChecklist.com meticulously unpacks the nuances of anxiety disorders , providing in-depth insights into their symptoms, triggers, and effective management strategies.
  • By bridging scientific research with practical application, the platform ensures a personalized approach to anxiety management.

Customer Onboarding is now an Established and Critical Component of the Customer Journey: 2024 Rocketlane Survey

Retrieved on: 
Tuesday, January 30, 2024

SAN JOSE, Calif., Jan. 30, 2024 /PRNewswire/ -- Continuing its commitment to enhancing customer onboarding and implementation initiatives, Rocketlane , the collaborative customer onboarding and PSA platform, proudly announces the release of their survey report, "The State of Customer Onboarding 2024".

Key Points: 
  • SAN JOSE, Calif., Jan. 30, 2024 /PRNewswire/ -- Continuing its commitment to enhancing customer onboarding and implementation initiatives, Rocketlane , the collaborative customer onboarding and PSA platform, proudly announces the release of their survey report, "The State of Customer Onboarding 2024".
  • The report delves into the evolving landscape of customer onboarding and reveals the top challenges for onboarding teams.
  • These insights underscore the critical role of customer onboarding in driving revenue growth and enhancing customer satisfaction in today's landscape.
  • 2024 is the year for teams to move away from running as cost centers to charging for crucial onboarding services to keep customers accountable and empower customer onboarding teams to drive increasing value," customer onboarding expert Donna Weber says in the report.

Tom Wilkinson: an actor of great humanity who seldom played the lead but dominated the screen

Retrieved on: 
Friday, January 5, 2024

Wilkinson seldom played the leading man, and yet he often dominated the screen.

Key Points: 
  • Wilkinson seldom played the leading man, and yet he often dominated the screen.
  • Wilkinson’s Benjamin Franklin is a clever, witty, cantankerous extrovert, often dominating scenes because he has the most dialogue.
  • In many ways, that was unusual in the characters Wilkinson portrayed (with the exception perhaps of Arthur Edens in 2007’s Michael Clayton).

Low-key roles that shine

  • His homosexuality isn’t commented on by the other characters, and Wilkinson carries it with the confidence of full acceptance.
  • Again, the quiet confidence in the conviction of having been born in the wrong body shines through Wilkinson’s performance.
  • But in the end, it is clear that his moral compass is functioning better than that of his fellow clerics.
  • His impeccable performances will be long remembered, and will serve to remind us of what we have lost in Tom Wilkinson.


Looking for something good? Cut through the noise with a carefully curated selection of the latest releases, live events and exhibitions, straight to your inbox every fortnight, on Fridays. Sign up here.
Elke Weissmann does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.

Menendez indictment looks bad, but there are defenses he can make

Retrieved on: 
Monday, September 25, 2023

Reactions came quickly to the federal indictment on Sept. 22, 2023, of New Jersey’s senior U.S. senator, Democrat Bob Menendez.

Key Points: 
  • Reactions came quickly to the federal indictment on Sept. 22, 2023, of New Jersey’s senior U.S. senator, Democrat Bob Menendez.
  • What did you think when you first read this indictment?
  • In addition, as judges routinely instruct juries in these cases, the indictment is not evidence and the jury may not rely on it to draw any conclusions.
  • The average reader will look at the indictment and say, “These guys are toast.” But are there ways Menendez can defend himself?
  • There are a number of complex issues presented by these charges that could be argued by the defense in court.
  • First, while the indictment charges a conspiracy to commit bribery, it does not charge the substantive crime of bribery itself.
  • In the Abscam case, seven members of the House and one Senator were all convicted in a bribery scheme.

ERYTECH Responds to Akkadian’s Disinformation

Retrieved on: 
Monday, June 12, 2023

Cambridge, MA (U.S.) and Lyon (France), June 12, 2023, 7:00 am CEST – ERYTECH Pharma (Nasdaq & Euronext: ERYP), today reacts to a series of disinformation attempts by Akkadian Partners to try and destabilize ERYTECH.

Key Points: 
  • Cambridge, MA (U.S.) and Lyon (France), June 12, 2023, 7:00 am CEST – ERYTECH Pharma (Nasdaq & Euronext: ERYP), today reacts to a series of disinformation attempts by Akkadian Partners to try and destabilize ERYTECH.
  • The proposed transaction is structured as a merger of PHERECYDES into ERYTECH, pursuant to which PHERECYDES shareholders will receive 15 new ERYTECH shares for every 4 PHERECYDES shares they own.
  • On 13 April, Akkadian Partners, an entity domiciled in Luxembourg, crossed the threshold of 5% of the share capital of ERYTECH Pharma.
  • Finally, it is important to note that a failure of the merger would only lead to the destruction of value for ERYTECH and its shareholders.

Edible Garden Kicks-Off Summer Season- Broadens Distribution at King Kullen and IGA Locations Across Long Island, New York

Retrieved on: 
Thursday, June 1, 2023

BELVIDERE, NJ, June 01, 2023 (GLOBE NEWSWIRE) -- Edible Garden AG Incorporated (“Edible Garden” or the “Company”) (Nasdaq: EDBL, EDBLW), a leader in controlled environment agriculture (CEA), locally grown, organic and sustainable produce and products, today announced an expansion of its distribution partnership with King Kullen and IGA across all of their retail locations on Long Island, New York.

Key Points: 
  • Mr. Jim Kras, Chief Executive Officer of Edible Garden, commented, "We are pleased to broaden our distribution at both King Kullen and IGA retail locations across Long Island, New York, in time for the 2023 summer season.
  • In response to growing consumer demand for the fresh produce and herbs that Edible Garden has built its reputation on, both King Kullen and IGA have doubled the shelf space that they have allocated in their retail locations for Edible Garden products.
  • By increasing the shelf space allocated to Edible Garden produce and products, both King Kullen and IGA are providing a solution to meet the growing consumer demand.”
    “We are delighted to step up and supply King Kullen and IGA retail locations on Long Island with all the produce they need to meet their customer demands.
  • Moreover, this expansion of our distribution offers us an opportunity to increase third-quarter revenue, which is traditionally the lightest quarter of the year for Edible Garden.

DC Council and DC Coalition to End Sexual Violence Recognize Sexual Assault Awareness Month, Honor Network for Victim Recovery of DC

Retrieved on: 
Wednesday, April 19, 2023

On Wednesday, April 19, SAAM was formally recognized by the Council of the District of Columbia in partnership with the DC Coalition to End Sexual Violence (DCCESV) with a ceremonial resolution.

Key Points: 
  • On Wednesday, April 19, SAAM was formally recognized by the Council of the District of Columbia in partnership with the DC Coalition to End Sexual Violence (DCCESV) with a ceremonial resolution.
  • The resolution urges residents to show their support for survivors and prevent and end sexual assault, abuse, harassment, online harassment and sex trafficking.
  • "I'm honored to join the DC Coalition to End Sexual Violence in recognizing this year's Sexual Assault Awareness Month," said DC Councilmember Charles Allen.
  • "Sexual Assault Awareness Month creates a yearly opportunity for folks to have more open conversations about sexual assault awareness and prevention," said Naida Henao, Esq., Head of Engagement at NVRDC.

Applied Underwriters Announces 2023 - 2024 Plans for Nation's Largest Amateur Golf Tournament, the Applied Underwriters Invitational, with Anticipated 11,000 Golfers Set to Compete to Benefit 65 National and Local Charities

Retrieved on: 
Tuesday, April 11, 2023

OMAHA, Neb., April 11, 2023 /PRNewswire/ -- Applied Underwriters, a global risk services leader, has set the dates for the world's most successful charity golf event, the 2023-2024 Applied Underwriters Invitational. Mr. Jamie Sahara, President of Applied Underwriters, has announced that The Invitational will start on June 3, 2023 and culminate May 1-5, 2024 as winning foursomes from the series of 75 tournaments will be invited to compete in the National Finals for the first time ever at Big Cedar Lodge in Ridgedale, Missouri.

Key Points: 
  • We have made a long-term commitment to it, to the growing amateur field and to the charities that need our help.
  • I urge amateur golfers everywhere to step up their game and step up for charity."
  • The Applied Underwriters Invitational opens on June 3, 2023 in Pinckney, MI.
  • Those interested in participating in the tournament as sponsors, golfers, charities, and spectators should visit invitational.com .

Sandpiper Group to FCR: Stop Spinning the Truth. It’s Time for Honest Engagement.

Retrieved on: 
Friday, February 24, 2023

Now we have a Board of 10, with at least eight incumbent trustees loyally rowing with management.

Key Points: 
  • Now we have a Board of 10, with at least eight incumbent trustees loyally rowing with management.
  • Below is a copy of the email exchange:
    Samir, thank you for your time and our discussions over the last few weeks.
  • Sandpiper may engage the services of one or more agents and authorize other persons to assist in soliciting proxies on behalf of Sandpiper.
  • Sandpiper has retained Morrow Sodali (Canada) Ltd. (“Morrow Sodali”) to assist Sandpiper in soliciting proxies of unitholders.