Investigator Brochure. The Company will provide a current Investigator Brochure for all applicable components of the Test Article, and any later revisions and addenda to the Investigator Brochure for the Test Article to the NIAID, as mutually agreed by the Parties.
Investigator Brochure. 6. Informed Consent Form 7. Payment schedule 8. Communication between the Parties Seznam příloh:
Investigator Brochure. No. 5 - Informed Consent form No. 6 – Insurance contract No. 7 – Power of attorney Přílohy:
Investigator Brochure. Each Party shall be responsible for (a) drafting and updating as necessary the investigator’s brochure for its Compound, and (b) filing all necessary Regulatory Documentation for its Compound with each applicable Regulatory Authority.
Investigator Brochure. “IB”): A compilation of the clinical and non-clinical data on the Investigational Medicinal Product(s) which is relevant to the study of such Investigational Medicinal Product(s) in human subjects. Investigational Medicinal Product (“IMP.”) A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a Clinical Study, including a product with a Marketing Authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use.
Investigator Brochure. Product Monograph
Investigator Brochure. 5. Informed Consent Form 6. Payment schedule 7. Communication between the Parties Seznam pšíloh:
1. Povolení SÚKL
2. Povolení MEK
3. Povolení LEC
4. Informace pro zkoušejícího 5. Informovaný souhlas pacienta 6. Platební pšíloha 7. Způsoby komunikace mezi stranami
1. COMMUNI CATI ON VIA ELECTRONI C MAIL ( “E-MAI L”)
Investigator Brochure. 21 CFR 312.55 (a); ICH E6 5.12, 7.3 a) Content x xUpdates only
Investigator Brochure. Zoznam Príloh
1. Protokol štúdie
2. Povolenie ŠÚKL – notársky overená kópia
Investigator Brochure. Labeling, packaging and package insert text, design, images, and logos.
