Hello,
I am looking for an EMA guideline, RP, ... that describes the use of the ALCOACCEA principles in paper documentation.
What i found is this [URL="http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2010/08/WC500095754.pdf"]reflection paper[/URL] which is related to eletronic data.
I would appreciate any orientation on that,
Kind regards,
Otto