1. NL actoren
   1. Miriam Sturkenboom
      1. UMC Utrecht
      2. cv
      3. persoonlijk
   2. Eugène Puijenbroek
      1. RUG
   3. EMA =
      1. Van Dissel
   4. Lareb
      1. Agnes Kant
2. Structuur van veiligheidsbewaking
   1. Overzicht: vac4eu.org/covid-19-vaccine-monitoring/ {404 error?}
   2. voorafgaand aan vergunning
      1. trial data
         1. online RMP EMA
      2. lijst van AESI
         1. ACCESS
            1. 27 AESI
            2. Narcolepsy
            3. Death, Sudden death
            4. ""Death was added. It is on this list because it clearly is able to derail the vaccination campaign if that would happen, so you need to be ready to know that."
            5. Covid 19
            6. 8 template protocols
            7. "ready to go if it's needed"
            8. template protocols
            9. "paraatheid"
            10. leren van H1N1
            11. (Narcolepsie)
            12. VAC4EU
            13. Global Vaccine Data Network
            14. Respond rapidly when safety concerns occur.
      3. Definities
         1. ACCESS
            1. 9-2021 AESI, codes & deinitions, maternal and neonatal outcomes
      4. Vóórkomen
         1. ACCESS
            1. background rates AESI 15-2-2021
            2. voorbeeld: 23 doden in nursing home stelt niets voor, want 300-400 doden/week is normaal in die groep
            3. = Rapid Signal Assessment
   3. Monitoring
      1. spontane rapportage
         1. Eudravigilance database
         2. Voorbeeld V-safe (USA-CDC)
            1. Reactogenicity
            2. eerste week
            3. pijn/vermoeidheid/hoofdpijn/spierpijn/rillingen/koorts/zwelling/gewrichtspijn/zenuwpijn
            4. "the system works"
      2. Cohort Event monitoring
         1. EMA: Early C19 vaccine monitor project
            1. App based data collection
            2. V-safe USA, V-safe Duitsland
            3. SafeVac2.0 NL
      3. + Brondata monitoring
         1. "if needed..." EN€EPP
            1. European Network of Centers for Pharmacoepidemiology and Pharmacovigilance
            2. SIGMA consortium
            3. Prof Ron Herings
            4. Sturkenboom
            5. Olaf Klungel
         2. EMA: tendering specific projects
   4. manufacturer studies
      1. access to Electronic health care data
         1. e.g. Sentinel
         2. VAC4EU
            1. "Systems can be used for public and private research"
3. organisaties
   1. VWS
      1. CBG
         1. Lareb
      2. RIVM
   2. UMC
   3. INTERNATIONAAL
      1. WHO
      2. EU
         1. EMA
            1. PRAC
         2. Netwerken
            1. SIGMA
            2. VAC4EU
      3. USA
         1. CDC
4. algemeen
   1. Zie video 2021
      1. https://youtu.be/BIPW4KpMras?si=854ZbfT-LirLwsQZ
   2. Routine
      1. Data Clinical trials (CT) in RMP
         1. RMP = Risk Management Plan
         2. "publicly available"
         3. N.B. de uitvoering en interpretatie van de CT is dubieus of zelfs frauduleus, zie: https://open.substack.com/pub/cmichels24/p/retraction-of-nejm-articles-polack?r=tj3kc&utm_medium=ios
      2. spontaan rapporteren
         1. Vaers
         2. Eudravigilance
         3. Vigibase
            1. global, WHO initiative
         4. enz.
   3. Additioneel
      1. signaaldetectie en monitoring
      2. "Rapid Assessment"
      3. Signaal evaluatie capaciteit
   4. Ontbreekt: Pathologie