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2022 - Coggle Diagram
2022
Case Management
EVWEB
FU einholen DE
Entry in Pheda
FU anfordern aus Ländern
Melden/ ACK ablegen
Cases Approven
:recycle:Process optimization :checkered_flag:
Reconciliation
Clinical Trial Support
DSUR (SH)
DSUR learning :confetti_ball: - on hold
SUSAR/ SESAR
SUSAR reporting
Requesting Queries
Abstimmung
Meldung im Rahmen der CT-Regulation
Training needed! :fire:
Document support / (e)TMF Support
eTMF Maintainance
SAE enter in UAW List
Neue Länder fit machen
SOPs ausrollen
Globales LMS
Qualifizieren
Contracts
JD
Monthly Reports lesen
PSUR Schreiben
Abstimmung
Learning + Documentation :checkered_flag:
SAP Data retrieval (automated) :red_cross:
PSUR Shedule Harmonization
Safety Relevant Text updates
PSUSA /CMDh/ PRAC ... (Competent Authority)
Originator Adaptation
Variation tracken
Originator Adoption based on CCDS
Literatur Recherche
Global
MLM
Adis
BPI Pooling
DE
AT
UAE
Quality Process
SOP schreiben
Update SOP
Deviations erstellen
Trainings geben
Globales PV Training [Learning Team]
LPVM Traiing [Learning Team]
Training entwerfen (alle) :star:
Support für MR:red_flag:
Zulassungsrelevante Dokumentation überarbeiten
MAA/NDA
Texte Freigeben
2.4/2.5 Review
Edu Material
LoQ
RMP
Data Privacy in PV
Contracts
Sub Contracts
Working Instruction
DFSA
CCDS/CCSI Projekt
CCDS Erstellen
Prozess aufsetzen
Audits
LRO/LLE
Paperbased Audits für Supplier
Contract Management
Ablage strukturieren :fire:
People Management
Onboarding new Team Members (all) [RS]
Article 57 Database + IDMP Project :explode:
Signal Management
PSMF Maintenance :champagne:
an trainings teilnehmen
New Products / DD Erstellen
Soc/DOMA Process support
Stufenplanbeauftragter sein
QPPV sein
Due Dilligance M&A