Appendix 5 | TOPRA

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Question 33: Please specify which other areas if you answered 'Other' in question 32

Responses
local Pharmacovigilance
Support to R&D project work
Training
Pharmacovigilance - now second point of contact but was previously first.
CMC
Technical Complaints
Human resources Health and safety
Pharmacovigilance
Readability Testing
health economics
BD, QP and Medical Writing
Regulatory intelligence & responses to global CMC guidelines for biotech products.
Some toxicology issues
authority liaison, submissions, clinical development, advisory, QC, data integration etc
Management
Clinical Endpoint Development; Pharmacovigilance
Pharmacovigilance intelligence
Patient Information Leaflet User Testing, Pharmacovigilance
Pharmacovigilance
Electronic submissions
Local CMC/manufacturing