Source: Regulatory and procedural guidelines (human and veterinary) Category: Regulatory and procedural guidelinesBy Ralphc4th July 2018 Author: Ralphc Post navigationPreviousPrevious post:Regulatory and procedural guideline: Draft qualification opinion on Cellular therapy module of the European Society for Blood & Marrow Transplantation (EBMT) Registry, draft: consultation openNextNext post:Regulatory and procedural guideline: Post-orphan medicinal product designation procedures: guidance for sponsors to submit an application via the current existing submission process until 19 Sept 2018Related postsRegulatory and procedural guideline: EudraVigilance registration manual26th July 2018Regulatory and procedural guideline: Qualification opinion on dopamine transporter imaging as an enrichment biomarker for Parkinson’s disease clinical trials in patients with early Parkinsonian symptoms, adopted19th July 2018Regulatory and procedural guideline: Post-orphan medicinal product designation procedures: guidance for sponsors to submit an application via the current existing submission process until 19 Sept 201819th July 2018Regulatory and procedural guideline: Draft qualification opinion on Cellular therapy module of the European Society for Blood & Marrow Transplantation (EBMT) Registry, draft: consultation open29th June 2018Regulatory and procedural guideline: Quality Review of Documents general principles regarding the summary-of-product-characteristics information for a generic / hybrid / biosimilar product27th June 2018Regulatory and procedural guideline: Procedure for orphan-medicinal-product designation: Guidance for sponsors submitting an application via the current existing submission process until 19 Sept 201822nd June 2018
Regulatory and procedural guideline: Qualification opinion on dopamine transporter imaging as an enrichment biomarker for Parkinson’s disease clinical trials in patients with early Parkinsonian symptoms, adopted19th July 2018
Regulatory and procedural guideline: Post-orphan medicinal product designation procedures: guidance for sponsors to submit an application via the current existing submission process until 19 Sept 201819th July 2018
Regulatory and procedural guideline: Draft qualification opinion on Cellular therapy module of the European Society for Blood & Marrow Transplantation (EBMT) Registry, draft: consultation open29th June 2018
Regulatory and procedural guideline: Quality Review of Documents general principles regarding the summary-of-product-characteristics information for a generic / hybrid / biosimilar product27th June 2018
Regulatory and procedural guideline: Procedure for orphan-medicinal-product designation: Guidance for sponsors submitting an application via the current existing submission process until 19 Sept 201822nd June 2018