Terminology

• Date
  - Monday, 27 May 2024 - Wednesday, 29 May 2024
  Location
  - Online
  Event summary
  EudraVigilance is the EU’s system for managing and analysing information on adverse reactions to medicines which have been authorised or are being studied in clinical trials in the European Economic Area (EEA) and supports the reporting and analysis of suspected adverse reactions originating from clinical trials and the post-authorisation phase of medicinal products.
• Following the Announcement of the EMA Management Board, the use of the ISO Individual Case Safety Report (ICSR) standard based on the ICH E2B(R3) modalities became mandatory on 30 June 2022 for all reporting to EudraVigilance.
• Furthermore, the use of ISO standard terminology for pharmaceutical dose forms and route of administration also became mandatory at the same time.
• Following the completion of this course, participants who pass the knowledge evaluation will receive a notification from the EMA.

• Following the Announcement of the EMA Management Board1, the use of the ISO Individual Case Safety Report (ICSR) standard based on the ICH E2B(R3) modalities became
  mandatory on 30 June 2022 for all reporting to EudraVigilance.
• Furthermore, the use of ISO standard terminology for pharmaceutical dose forms and route of administration also became mandatory at the same time.
• Following the completion of this course, participants who pass the knowledge evaluation will receive a notification from the EMA.
• Organisations which aim to register first user QPPV/RP or to use EudraVigilance web application (EVWEB) to start the electronic reporting of ICSRs to EudraVigilance for the first time, need to provide such notification for at least one user to the EMA to be able to successfully register with the EV production environment.

• Following the Announcement of the EMA Management Board1, the use of the ISO Individual Case Safety Report (ICSR) standard based on the ICH E2B(R3) modalities became
  mandatory on 30 June 2022 for all reporting to EudraVigilance.
• Furthermore, the use of ISO standard terminology for pharmaceutical dose forms and route of administration also became mandatory at the same time.
• Following the completion of this course, participants who pass the knowledge evaluation will receive a notification from the EMA.
• Organisations which aim to register first user QPPV/RP or to use EudraVigilance web application (EVWEB) to start the electronic reporting of ICSRs to EudraVigilance for the first time, need to provide such notification for at least one user to the EMA to be able to successfully register with the EV production environment.

• Recently a politician from a village in Prince Edward Island displayed an offensive sign on his property in which he proclaimed there is a “mass grave hoax” regarding the former Indian Residential Schools in Canada.
• Although many have called for him to resign, he is just one of many people who subscribe to this false theory.
• A hoax is an act intended to trick people into believing something that isn’t true.

There is no media conspiracy

• As two settler academic researchers, we decided to investigate the claims of a media conspiracy and fact-check them against evidence.
• To find out, we analyzed 386 news articles across five Canadian media outlets (CBC, National Post, the Globe and Mail, Toronto Star and The Canadian Press) released between May 27 and Oct. 15, 2021.

‘Preliminary findings’ of ‘unmarked burials’

• A National Centre for Truth and Reconciliation Memorial Register has to date confirmed the deaths of more than 4,000 Indigenous children associated with residential schools.
• But the Truth and Reconciliation Commission (TRC) noted its register of missing children was incomplete, partly due to a large volume of yet-to-be-examined and destroyed records.

Countering harmful misinformation

• In the two years since, a number of commentators, priests and politicians, including the P.E.I councillor with his sign, have downplayed the harms of residential schooling — or questioned the validity, gravity and significance of the the Tk’emlúps te Secwépemc First Nation’s announcement.
• We hope that our research can contribute to this work and that our report helps to debunk the “mass grave hoax” narrative specifically.

Cherry-picked ‘evidence’

• Myths, however, are not pure fiction; they often contain a kernel of truth that is exaggerated or misrepresented.
• This selective representation of evidence is commonly referred to as cherry-picking, and it’s easy to see how those spreading the “mass grave hoax” narrative rely on cherry-picked evidence.
• By September, denialists were misrepresenting the extent of media errors to push the conspiratorial “mass grave hoax” narrative online.
• And we hope our report sparks a national conversation about how important language is when covering this issue.

Challenging Residential School denialism

• According to Daniel Heath Justice and Sean Carleton (one of the authors of this story), residential school denialism is not the denial of the residential school system’s existence.
• Read more:
  Truth before reconciliation: 8 ways to identify and confront Residential School denialism

  Residential school denialism, like climate change denialism or science denialism, cherry-picks evidence to fit a conspiratorial counter-narrative.

Truth before reconciliation

• This is the strategy of disempowering and discrediting residential school denialism advocated by former TRC Chair Murray Sinclair.
• We hope others will join us in this type of research to help Canadians learn how to identify and confront residential school denialism and support meaningful reconciliation.
• As the Truth and Reconciliation Commission said in its final report, without truth there can be no genuine reconciliation.