Are there requirements or ways to prepare yourself for a training/mentorship?
Are there requirements or ways to prepare yourself for a training/mentorship?
Yes, I would suggest reading and poking around on the following pages (as you can see, EMA is all over the place, I recommend saving all links in your browser if you want to refer to them regularly):
QRD templates & appendices: https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/product-information/product-information-templates-human
QRD stylistic requirements: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/compilation-quality-review-documents-stylistic-matters-product-information_en.pdf
Guidelines for excipients: https://www.ema.europa.eu/en/annex-european-commission-guideline-excipients-labelling-package-leaflet-medicinal-products-human
Terms for batch and expiry date: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/qrd-appendix-iv-terms-abbreviations-batch-number-expiry-date-be-used-labelling-human-medicinal_en.pdf
Tables of non-standard abbreviations: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/tables-non-standard-abbreviations-be-used-summary-product-characteristics_en.pdf
EDQM termbase - required terminology, you can create an account for free (if working for RWS, you will receive it as a MultiTerm desktop termbase): https://standardterms.edqm.eu/#
MedDRA - required terminology, but only in some languages (if working for RWS, you will receive it as a MultiTerm server-based termbase): https://www.meddra.org/basics
CHMP Meetings - the meeting dates are the foundation upon which variation deadlines are based: https://www.ema.europa.eu/en/committees/chmp/chmp-meetings
Happy reading!!
Yes, I would suggest reading and poking around on the following pages (as you can see, EMA is all over the place, I recommend saving all links in your browser if you want to refer to them regularly):
QRD templates & appendices: https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/product-information/product-information-templates-human
QRD stylistic requirements: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/compilation-quality-review-documents-stylistic-matters-product-information_en.pdf
Guidelines for excipients: https://www.ema.europa.eu/en/annex-european-commission-guideline-excipients-labelling-package-leaflet-medicinal-products-human
Terms for batch and expiry date: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/qrd-appendix-iv-terms-abbreviations-batch-number-expiry-date-be-used-labelling-human-medicinal_en.pdf
Tables of non-standard abbreviations: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/tables-non-standard-abbreviations-be-used-summary-product-characteristics_en.pdf
EDQM termbase - required terminology, you can create an account for free (if working for RWS, you will receive it as a MultiTerm desktop termbase): https://standardterms.edqm.eu/#
MedDRA - required terminology, but only in some languages (if working for RWS, you will receive it as a MultiTerm server-based termbase): https://www.meddra.org/basics
CHMP Meetings - the meeting dates are the foundation upon which variation deadlines are based: https://www.ema.europa.eu/en/committees/chmp/chmp-meetings
Happy reading!!