Abuse

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.

Drug Abuse Testing Market, Size, Global Forecast Report 2024-2030: Focus on Alcohol, Cannabis/Marijuana, Cocaine, Opioids, Amphetamine & Methamphetamine, and LSD - ResearchAndMarkets.com

Retrieved on: 
Tuesday, March 5, 2024

Drug of Abuse Testing Market size is expected to hit US$ 10.28 Billion by 2030 from US$ 6.18 Billion in 2023.

Key Points: 
  • Drug of Abuse Testing Market size is expected to hit US$ 10.28 Billion by 2030 from US$ 6.18 Billion in 2023.
  • Innovations in technology are continuously emerging to expedite and enhance drug testing efficiency in response to the growing demand for such services.
  • The drug abuse testing market is generally pushed by strict laws that mandate drug abuse testing, growing government initiatives concerning drug abuse, rising consumption of alcohol and different drugs, and growing mortality because of drugs.
  • The growing global population engaged in alcohol and illicit drug use, encompassing substances like marijuana and cocaine, drives the drug abuse testing market's growth.

Cloudflare Firewall for AI Will Help Secure AI Applications, At Scale and For Free

Retrieved on: 
Monday, March 4, 2024

A recent study revealed that only one in four C-suite level executives have the confidence that their organizations are well-prepared to address AI risks.

Key Points: 
  • A recent study revealed that only one in four C-suite level executives have the confidence that their organizations are well-prepared to address AI risks.
  • “With Cloudflare’s Firewall for AI, we are helping build security into the AI landscape from the start.
  • Cloudflare will help enable customers to:
    Rapidly detect new threats: Firewall for AI may be deployed in front of any LLM running on Cloudflare’s Workers AI.
  • Cloudflare Firewall for AI will add additional layers to its existing comprehensive security platform , ultimately plugging the threats posed by emerging technology.

Top court: No letup in anti-cyberbullying battle

Retrieved on: 
Friday, March 8, 2024

Zhang added, "This increasingly serious cyberbullying makes people worry about being victimized, whether online or offline, polluting the online environment and disrupting social order."

Key Points: 
  • Zhang added, "This increasingly serious cyberbullying makes people worry about being victimized, whether online or offline, polluting the online environment and disrupting social order."
  • Such specific rules will help prosecutors play a bigger role in combating cyberbullying, giving stronger support to victims, Zhang said.
  • "These provisions aim to help create a safer online environment to guarantee the public sense of security," Zhang said.
  • Tragedies caused by online misconduct have caused public outrage and prompted cyberspace agencies and internet platforms to take action, in addition to courts.

Guardio Labs Uncovers Thousands of Compromised Domains Used to Send Mass Malicious Emails

Retrieved on: 
Monday, February 26, 2024

This malicious activity, dubbed "SubdoMailing", leverages the trust associated with these domains to circulate spammy and malicious phishing emails by the Millions each day, cunningly using their credibility and stolen resources to slip past security measures.. See here for the full research report.

Key Points: 
  • This malicious activity, dubbed "SubdoMailing", leverages the trust associated with these domains to circulate spammy and malicious phishing emails by the Millions each day, cunningly using their credibility and stolen resources to slip past security measures.. See here for the full research report.
  • "We're clearly facing a formidable operation characterized by significant expenditure and substantial revenue," said Nati Tal, Head of Guardio Labs at Guardio.
  • "At Guardio, our mission extends beyond merely detecting and blocking malicious emails and websites for our customers.
  • We encourage everyone to visit the "SubdoMailing" checker website at [ https://www.guard.io/subdomailing ] to ensure the security of their domains.

Acid attacks are a form of violence against women – the law needs to treat them as such

Retrieved on: 
Thursday, February 15, 2024

Sadly, acid attacks like this are not isolated incidents.

Key Points: 
  • Sadly, acid attacks like this are not isolated incidents.
  • Over the last 15 years, they have been on the rise across the world, including in the UK.
  • Those who target a victim’s face in particular aim to maim and disfigure, but not necessarily kill, their target.

Acid attacks as gendered violence

  • But what is often left out of the discussion is that it is a form of gendered violence that mainly targets women.
  • While acid attacks are perpetrated against both men and women, the vast majority of victims – 80% globally – are women, and the majority of perpetrators are male.
  • As a specialist in criminal justice responses to violence against women and girls, I have provided expert evidence in UK courts on the cultural contexts at play in cases of gender-based violence, including acid attacks.
  • Acid attacks remain common in India and the rest of South Asia, despite bans on the sale of acid over the counter.

How the law ignores violence against women

  • Although few acid attacks result in death, the intention to disfigure the victim permanently can still lead to a murder charge.
  • A number of UK women have reported not being taken seriously by police when they report threats of acid attacks.
  • Acid violence against women usually does not happen out of the blue.
  • This starts by acknowledging that these are not just horrific, random attacks – they are very often targeted violence against women.


Aisha K. Gill is affiliated with the End Violence Against Women Coalition

The Well Community For Women Opens New Coworking Location With Onsite Childcare in North Park

Retrieved on: 
Thursday, February 15, 2024

SAN DIEGO, Feb. 15, 2024 /PRNewswire/ -- At 70.4 percent, there are more moms of children under 5 in the workforce than ever before, and The Well Community For Women is supporting them. A 501(c)(3) organization based in San Diego, The Well is opening its second coworking, childcare, and resource center today at 3810 Bancroft Street in San Diego's North Park neighborhood. The Well and the San Diego Regional East County Chamber of Commerce will mark the occasion with a ribbon cutting today from 4 to 6 p.m. 

Key Points: 
  • The Well offers women a workspace, sense of community, and childcare for children ages 6 weeks to 5 years old.
  • A 501(c)(3) organization based in San Diego, The Well is opening its second coworking, childcare, and resource center today at 3810 Bancroft Street in San Diego's North Park neighborhood.
  • The Well's new San Diego location is open from 9 a.m. to 5 p.m., and its original La Mesa location is open from 9 a.m. to 3 p.m. at 5500 Grossmont Center Dr. Ste.
  • Coworking memberships in La Mesa range from $50/day to $600/month plus the option to add childcare and enrichment activities, while North Park ranges from $60/day to $250/month plus the option to add childcare and enrichment activities.

ICO responds to Home Office’s draft regulations to the immigration exemption

Retrieved on: 
Monday, February 12, 2024

The Information Commissioner's Office has welcomed proposed government changes to provide clearer safeguards around how people in a potentially vulnerable position within the immigration system are able to access the information held about them.

Key Points: 
  • The Information Commissioner's Office has welcomed proposed government changes to provide clearer safeguards around how people in a potentially vulnerable position within the immigration system are able to access the information held about them.
  • The draft regulations will amend the immigration exemption in the Data Protection Act, and follows December's Court of Appeal ruling that required the government to make the exemption clearer.
  • The Home Office consulted with us about the new regulations and, after careful examination, we have determined that they satisfy the requirements of the judgment.
  • "While these regulations will be a welcome step forward, we have emphasised that staff working in immigration must be made aware of these changes and trained appropriately."

The rise of African prophets: the unchecked power of the leaders of Pentecostal churches

Retrieved on: 
Thursday, February 8, 2024

Charismatic Pentecostal prophets are known for leading megachurches like these that emphasise faith healing, health and wealth.

Key Points: 
  • Charismatic Pentecostal prophets are known for leading megachurches like these that emphasise faith healing, health and wealth.
  • A 2022 study conducted in 34 African countries confirmed this trend: 69% of respondents trusted religious leaders; 51% trusted their president.
  • Many followers believe it would be a demotion for a prophet to run for president because a prophet anoints leaders.
  • As an anthropologist who studies charismatic Pentecostal churches, particularly in Zimbabwe, I’ve carried out research on the power exercised by prophets.

The prophets

  • Charismatic Pentecostal churches are built around prophets who are viewed as possessing special gifts to mediate between humanity and God.
  • It’s common practice for charismatic Pentecostal prophets to threaten doubters with eternal condemnation, ailments or poverty.
  • Charismatic Pentecostal prophets are popular for their ability to heal ailments.

Big money

  • But charismatic Pentecostal movements, in general, lack transparency and accountability in managing “free will” donations.
  • With vast financial resources that aren’t taxed, charismatic Pentecostal prophets’ lavish lifestyles serve as “proof” of the prosperity gospel they preach – that faith attracts money – while their followers pool resources to finance church operations.

Political connections

  • Post-colonial political leaders in Africa largely view charismatic Pentecostal prophets as allies.
  • Relations with political leaders often span several countries, extending the network and influence of prophets beyond national borders.
  • Allegations of rape, corruption and fraud against prophets can be leniently dealt with due to these connections and protection.

Media empires

  • Charismatic Pentecostal prophets have an impact on the Africa media landscape through powerful television and social media presence.
  • These media channels are also spaces for shaping and managing the public image of prophets – and can be used to counter harmful allegations against them.

Members

  • Pentecostal members form an army of foot soldiers who engage in recruiting new followers.
  • Charismatic Pentecostal communities are tightly knit and coalesce around the men of God.
  • Relations between the clergy and laity are framed around familial bonds, with the prophet as the spiritual father or “Daddy”.
  • More than other religious groupings, charismatic Pentecostal prophets preside over economies that systemically facilitate the distribution of food, clothes, money and jobs within the church – often in the form of church donations to members considered poor.


Josiah Taru has previously received research funding from the Wellcome Trust and the Andrew Mellon Foundation.

Legal-Bay Pre-Settlement Funding Announces Renewed Focus on Wrongful Termination Cases

Retrieved on: 
Wednesday, February 7, 2024

SAN FRANCISCO, Feb. 7, 2024 /PRNewswire/ -- Legal-Bay LLC, The Pre Settlement Funding Company, reports today that a large portion of their pre-settlement cash advance funding capital will be directed toward victims of wrongful termination. Legal-Bay has vast experience with unlawful termination lawsuits. They've helped numerous plaintiffs who've been unfairly terminated for everything from sexual harassment to racial, gender, or age-related discrimination.

Key Points: 
  • SAN FRANCISCO, Feb. 7, 2024 /PRNewswire/ -- Legal-Bay LLC, The Pre Settlement Funding Company, reports today that a large portion of their pre-settlement cash advance funding capital will be directed toward victims of wrongful termination.
  • Based on recent court case trends, Legal-Bay anticipates even more wrongful termination lawsuit filings to come.
  • Chris Janish, CEO, commented on the company's focus of assisting plaintiffs in similar situations, "Wrongful termination cases can be tricky and take a long time to resolve.
  • Their loan for settlement funding programs are designed to provide immediate cash in advance of a plaintiff's anticipated monetary award.