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What are ATMPs (ENG)
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Showing 1 - 1 of 47 results
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Development phase
Basic Research
Basic Research
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FDA/EMA review
Post-market monitoring
Post-market monitoring
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Clinician
7
/9
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6
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21
/32
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5
/6
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33
/64
QA personnel
11
/29
QC personnel
10
/21
Regulatory assurance expert
17
/20
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7
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36
/68
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19
/44
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47
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/13
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/7
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/17
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/30
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/6
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ATMP
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/10
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CAR T
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Cell technology
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/10
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GMP&GDP training courses
GMP and GDP
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Clinical case studies on CART
CAR T case studies
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Immuno-oncology
Tumor immunology, check point blockades, CAR T and other novel therapies
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Pharmaceutical Development of ATMPs Training Course
Comprehensive overview of the regulatory, quality and good manufacturing practice (GMP) requirements to consider when developing advanced therapy medicinal products (ATMPs).
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Cell & gene therapy (ATMP) development
Key challenges of the ATMPs development cycle – Scientific, Manufacturing, Reimbursement and Regulatory
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Advanced Therapy Manufacturing
Cell/gene therapy manufacturing, quality assurance, product development pathways, GMP compliance, Investigational Medicinal product dossier writing, biosafety
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Cell and Gene Therapy Bioprocessing
Challenges of translating scientific discoveries into medicinal products such scaling up lenti-viruses
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Advanced Therapies GMP Onboarding
Advanced course on GMP requirements, QMS, quality controls
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CAR-T e-courses
different modules, ranging from patient selection, evaluation, treatments and follow-up, to collection of the starting material by apheresis, reception, delivery and administration
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Market approval
Market approval
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Performing Clinical Trials for ATMPS
Basic pricipals of clinical trials, factors needs to consider for designing a successful ATMP based clinical trials
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Determining the Strategy for Bringing Your Therapy to the Patient
Develop a strategic plan and a business plan for ATMP
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Introduction to CAR-T cells therapies for Data Managers
Introducttion to CAR T, reporting on CAR T outcome and frequent complications
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CAR T-celbehandeling: ontwikkelingen en overwegingen
Overview of CART-therapies, eligiblity of CAR trials, what so you need to take into account for car trials
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Introduction to cell therapy
Instruction within cell therapy processes and manufacturing under good manufacturing practice (GMP) procedures.
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Introduction to translational medicine
the concept of translational science and medicine
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Pilot Educational Program Oncology
Scientific advice and marketing authorisation assessments for human medicines with focus on oncology
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Regulatory affairs
Introduction to regulatory affairs, epidemiology and pharmacoepidemiology, pharmacovigilance, product information, marketing authorisations
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Regulatory plans for ATMP
regulatory aspects of ATMP, difference between EU, US and canadian regulatory system
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CAR-T: Historical Perspectives, Manufacturing and Clinical Applications
CAR-T: Basics and application
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Protecting Your Intellectual Property
Basic patent principles, IP rights in life sciences, patent information as a strategic tool
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Early Clinical Development (Phase I and II)
Principles of pharmacology, types of studies in early clinical development
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Non-clinical development
The courses of this module will explain non-clinical studies in detail, the concepts of pharmacogenetics and genomics and more.
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