Questions & Answers - Kick Off Meeting CHESSMEN, Rome, 10.02.2023

Referenced at:

• European Network

Assessment of the Advisory Board on Classification regarding Arthrobene Plus Gelenkskapseln (German only)

Referenced at:

• Decisions of the AGBR

definition of a gene therapygenetically modified organism In case of CUP with a medicinal product that fulfilsfulfills the definition of a gene therapy or with a medicinal product that constitutes a genetically [...] use of a non-licensed medicinal product or a medicinal product outside the limitations of the SmPC in a non-interventional study is no possible according to the definition in § 2a para 3 AMG. § 2a para 3 [...] According to § 8a paragraph 2 AMG the applicant for a CUP can either be a manufacturer, if also the sponsor of approved clinical trials for the respective medicinal product, or the applicant for a marketing

Referenced at:

• Compassionate use/Named Patient Use

m ur Sp on gi os a Ti bi a ko m pl et t Ti bi a D ia ph ys e Ti bi a Co rt ic al is Kn or pe l, Ch on dr o- zy te n Fa sz ie n M us ke lz el le n Sc hä de l- ka lo tt en An de re s A. ö. Krankenhaus der [...] , -h al s Fe m ur D ia ph ys e Fe m ur Co rt ic al is Fe m ur Sp on gi os a Ti bi a ko m pl et t Ti bi a D ia ph ys e Ti bi a Co rt ic al is Kn or pe l, Ch on dr o- zy te n Fa sz ie n M us ke lz el le [...] , -h al s Fe m ur D ia ph ys e Fe m ur Co rt ic al is Fe m ur Sp on gi os a Ti bi a ko m pl et t Ti bi a D ia ph ys e Ti bi a Co rt ic al is Kn or pe l, Ch on dr o- zy te n Fa sz ie n M us ke lz el le

Referenced at:

• Tissue vigilance

Assessment of the Advisory Board on Classification regarding RUMA Marker (German only)

Referenced at:

• Decisions of the AGBR

national companies. The list is arranged alphabetically according to applicants or sites and shows whether a procedure is being actively processed or whether (re)action is required by our customers (clock stop); [...] the eService inspections & surveillance: authorisations and certificate confirmations inspection of a design qualification third country (re)inspections (de-) registration of brokers (de-) registration [...] EudraGMDP The new regulatory framework for veterinary medicinal products (Regulation 2019/6 and 2021/16, Article 9(h)) requires the following changes to the EudraGMDP database, which will be implemented

03.2023 2/9 1 APPLICATION FOR APPROVAL OF A VETERINARY CLINICAL TRIAL 1.1 Content of the application An application for the approval of a clinical trial of a veterinary medicinal product in accordance [...] refused by a negative decision (see 3.3.3). In case of a satisfactory response to the open questions, the BASG will authorise the application for approval of the clinical trial by means of a positive decision [...] and Animal Welfare Committee (“ETK”)/Animal testing permit A clinical trial may not be started until the animal study has been approved and a positive opinion has been received by the responsible Ethics

Referenced at:

• Clinical trials

Antrag auf Ausstellung einer Bestätigung Sachkundige Person, Herstellungsleiter, Kontrolllaborleiter nach der Arzneimittelbetriebsordnung 2009

Referenced at:

• FAQ - reportable qualified persons
• FAQ - reportable qualified persons
• Good manufacturing / distribution practices (GMP/GDP)

Action at EU level The European Medicines Agency (EMA) has scientifically reassessed the serious, disabling and potentially permanent side effects of quinolone and fluoroquinolone antibiotics taken orally, injected or inhaled. This assessment also…

Nebenwirkungen Alter in Jahren Anzahl Personen unbekannt 416 über 75 329 65-75 161 45-64 5.710 18-44 10.644 16-17 20 Geschlechterverteilung Abbildung 2. Geschlechterverteilung der Personen mit vermuteten Nebenwirkungen [...] 26 AstraZeneca). Bei 46 Patient*innen konnte der Gesundheitszustand wiederhergestellt werden. Bei 16 weiteren läuft noch die Abklärung bzw. konnten noch keine weiteren Informationen eingeholt werden. [...] konnte aufgrund des Obduktionsberichts ein Zusammenhang mit der Impfung ausgeschlossen werden. Bei 16 Personen fiel die Bericht über Meldungen vermuteter Nebenwirkungen nach Impfungen zum Schutz vor COVID-19

Referenced at:

• Reports COVID-19 Vaccination