Examples of Therapeutic Indication in a sentence
Therapeutic Indication: the proposed indication for the marketing authorisation, based on the sponsor’s expectations at the time of the orphan designation application.
Therapeutic Indication: the proposed indication(s) for the future marketing authorisation, based on the sponsor’s expectations at the time of the orphan designation application.
NoYesEmployment with company/institution If ‘YES’, please provide details below: Company/ InstitutionRole/FunctionProduct, Therapeutic Indication, ManufacturerTime Period MM/YYYY – MM/YYYY <Please add more rows if needed> 2.2 Consultancy <’Consultancy’ means provision of advice (including training on a one-to-one basis, preparation of HTA reports or HTA submission) to a company/institution (as defined in 2.1), regardless of contractual arrangements or any form of remuneration.
Any future Therapeutic Indication must be completely covered within the scope of the designated ‘Orphan Condition’.
NoYesEmployment with company/institution If ‘YES’, please provide details below: Company/ InstitutionRole/FunctionProduct, Therapeutic Indication, ManufacturerTime Period MM/YYYY – MM/YYYY<Please addmore rows if needed> 2.2 Consultancy <’Consultancy’ means provision of advice (including training on a one-to-one basis, preparation of HTA reports or HTA submission) to a company/institution (as defined in 2.1), regardless of contractual arrangements or any form of remuneration.
If such a reason exists, this should be clarified in the guideline and consequently carried through the entire document.Rewrite as follows: ‘(d) Granted Therapeutic Indication: The therapeutic indication in adults and/or paediatric populations for which a product has already received marketing authorisation.
Maintain required regulatory training1.1 Ensure up-to-date training, for example:• Good Clinical Practices (GCP)• Safety training, as required• Good Pharmacoepidemiological Practices (GPP), as required• Therapeutic Indication, as needed• Company Standard Operating Procedures (SOPs)• Electronic Data Capture (EDC) 2.
The Document Custodian agrees that, with respect to any Underlying Instruments at any time or times in its possession, the Document Custodian shall be the agent of the Administrative Agent, for the benefit of the Secured Parties, for purposes of perfecting (to the extent not otherwise perfected) the Administrative Agent’s security interest in the Collateral and for the purpose of ensuring that such security interest is entitled to first priority status under the UCC.
Proposed Therapeutic Indication and Dosage RegimenNamenda XR is indicated for the treatment of moderate to severe dementia of Alzheimer’s type.
Approval of BLA by NMPA for 3rd Therapeutic Indication $[*] * If the Therapeutic Indication approved by the FDA in Milestone Nos.