Overcoming Combination Products Regulatory Challenges
Until now, combination products are more often handled inconsistently in different jurisdictions as drugs and/or devices. The determination as to which regulations, submission procedure and pathway to market is followed for the product is largely based on the its Primary Mode of Action, a new concept in itself.
Ahead of the Combination Products Forum 2018, we spoke exclusively to Viky Verna, Co-Founder and Vice President at confinis, in order to discuss the biggest challenges relating to the combination product regulatory landscape, the best compliance management approaches, and the industry’s outlook and direction towards regulation harmonisation.
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