Immunotherapy Courses

Definition of Advanced Therapy and medicinal products: ATMPs (EMA) vs Cellular and Gene Therapy products: CGT (FDA)
-Regulation of ATMPs: Why? regulation in EMA, FDA regions.
-EU regulatory framework for ATMP-specific legislation. EMA composition, activities related to ATMPs
-ATMPs Classification. EMA and FDA
-PRIME: priority medicines
-Regulation 1394/2007 on ATMPs : Rprovides the overall framework on ATMPs. The Regulation established the Committee for Advanced Therapies (CAT) as a multidisciplinary committee, whose primary responsibility is to assess the quality, safety and efficacy of ATMPs, and to follow scientific developments in the field 

ATMPs 1 -

ATMPs 2 -Oligonucleotides drugs
-Gene therapy medicinal product
-Somatic cell therapy medicinal product
-Tissue-engineered product
-Combined advanced therapy medicinal product
-Advanced therapy classification: EMA website/ ATMPs examples 

ATMPs 3 -Rare diseases and orphan designation
-Pediatric Medicines
-Challenges in ATMPs development
-Marketing authorisation procedures for ATMPs
-Pharmacovigilance for ATMPs
-Successes and failures of ATMPs
-Current landscape of ATMPs clinical development: Developing Novel Platforms to Advance the Delivery of ATMPs to Patients
-What are medical Devices. Differences between ATMPs and Medicinal Drugs. Legislation. Classification 

CAR cells therapies This section will try to provide students with basic knowledge in CAR cells therapies. -T cell activation. T cell receptor (TCR). Role in cancer cytotoxicity
-CAR-T cells
-Cancer stem cells and CAR-T cells
-CAR cells beyond T-cells: CAR-M,DC,Treg cells
-Current challenges and limitations of T-CAR therapies
-CAR cells beyond cancer

MUSE cells:

A new therapeutic approach for regenerative medicine
This section will try to provide students with basic knowledge in regenerative medicine and Multilineage-differentiating stress-enduring cells: MUSE cells a new therapeutic approach -Regenerative Medicine
-Stem cells
-Mesenchymal stem cell therapy
-Multilineage-differentiating stress-enduring cells: MUSE cells: definition, characteristics, functions, preclinical and clinical studies, comparison with other stem cells

Further details available by enquiry rocketprogram.es or Biochem123 Enquiries 

Fully accredited course units. Cost effective and accredited University in Spain provision. 

Enquire here for further details: 

rocketprogram.es or Biochem123 Enquiries 

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