Examples of 'post-authorisation' in a sentence
Meaning of "post-authorisation"
Post-authorisation is an adjective used in the context of regulatory approval processes, specifically referring to activities or measures that occur after official authorization has been granted
How to use "post-authorisation" in a sentence
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post-authorisation
Scientific guidance on post-authorisation efficacy studies.
Post-authorisation applications for centrally authorised.
Public health impact of post-authorisation activities.
Post-authorisation activities increased markedly during the.
Forecast opinions and post-authorisation activities.
Post-authorisation evaluation of medicines for human use.
Specific obligations to complete post-authorisation measures.
Format of post-authorisation safety studies.
Specific obligation to complete post-authorisation measures.
The number of post-authorisation applications and opinions.
Updating of EPARs to include information on post-authorisation activities.
Respiratory post-authorisation safety study.
Management of pharmacovigilance and relevant post-authorisation procedures.
Methods for post-authorisation control and monitoring purposes.
We do not retain sensitive authentication data post-authorisation.
See also
Supervision of post-authorisation safety studies.
Post-authorisation measures for the conditional marketing authorisation.
A requirement to conduct post-authorisation studies.
Trengthened post-authorisation monitoring of medicines for human use " pharmacovigilance.
Pharmacovigilance and post-authorisation safety.
Volume of post-authorisation procedures initiated for veterinary medicines remains stable.
Obligation to conduct post-authorisation measure.
Post-authorisation measures for the marketing authorisation under exceptional circumstances.
Obligations to conduct post-authorisation measures.
Post-authorisation activities relate to variations, line extensions and transfers of marketing authorisation.
Epidemiological method for a post-authorisation safety study.
Post-authorisation activities relate to variations, line extensions and transfers of marketing authorisations.
Pharmacovigilance and post-authorisation safety and efficacy of medicines.
A number of these inspections were conducted post-authorisation and.
Specific obligation to complete post-authorisation measures authorisation under exceptional circumstances.
Strengthened requirements for risk management and post-authorisation traceability ;.
A documentation of post-authorisation obligations that have been imposed as a condition of the marketing authorisation.
Protocols, abstracts and final study reports for post-authorisation safety studies.
Post-authorisation activities relate to variations, extensions of marketing authorisations and transfers of marketing authorisations.
Reinforcement of the scientific advice procedure to better address post-authorisation safetyrelated aspects.
Specific obligation to complete post-authorisation measures for the marketing authorisation under exceptional.
Sufficient validation is required for pre-authorisation methods and post-authorisation monitoring methods.
The legislative provisions governing post-authorisation inspections and controls have yet to be implemented.
Manage the increase in workload for initial marketing authorisation and post-authorisation applications.
Therefore the obligation to conduct post-authorisation studies should be imposed on the marketing authorisation holder.
In addition the marketing authorisation holders of chlormadinone should perform a post-authorisation safety study.
Methods that are considered suitable for post-authorisation monitoring must be clearly identified.
Ultimately, post-authorisation manufacture of cell therapy products will necessitate storage for numerous years.
It is also responsible for design and evaluation of post-authorisation studies and for pharmacovigilance inspections.
Methods for post-authorisation monitoring shall involve the use of commonly available reagents and equipment.
The format of protocols, abstracts and final study reports of the post-authorisation safety studies.
Post-authorisation services related to these applications entail the same revenues and costs as other applications.
A study testing possible interactions with amidase inhibitors is part of the post-authorisation development plan.
Methods for post-authorisation monitoring should involve the use of commonly available reagents and equipment.
For chlormadinone this will be investigated through a post-authorisation safety study, which is further discussed below.
