Discuss the suitability of current regulations for biotechnology medicinal products globally under the following four topics:
(i) Fitness for purpose
(ii) Impact on, and response to innovation
(iii) Impact on the access of medicines to patients
(iv) Any other suitable topic(s)
You should provide, where relevant, examples and identify the regulations
Title: Innovation in bio-similar development and its Implications towards more affordable medications.
The relevant information could be available in FDA, EMEA websites.
Good luck
Praveen
Thanks Praveen, thanks really helpful. Are there any specific guidelines that you would recommend I definitely don't miss out on?
Regards, Kanchan
Good Lord! There must be 4 PhD's dissertations in there!
I 1st would review ICH guidelines since they are international, then FDA and EMA (Britain's MHRA too) since they are national and regional.
Good Luck (you will need it)!
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