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Course Filters
Showing 1 - 1 of 62 results
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Development phase
Basic Research
Basic Research
Early discovery
Early discovery
Non-clinical development
Non-clinical development
Clinical development
Clinical development
FDA/EMA review
FDA/EMA review
Post-market monitoring
Post-market monitoring
Function
Clinician
5
/9
Data manager
6
Facility manager
24
/32
Patient representative
4
/6
Pharmacist
48
/64
QA personnel
18
/29
QC personnel
17
/21
Regulatory assurance expert
19
/20
Research nurse
4
/7
Scientist
53
/68
Technician
36
/44
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On Site
On Site
14
/35
Online
Online
43
/47
Brochure
Brochure
0
/1
Language
Chinese
1
Dutch
0
/28
English
62
Korean
1
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≤ 1 hour
16
/17
1 - 4 hours
9
/13
1 day
6
/7
4 - 8 hours
5
/17
Multi-day
22
/30
Varies per course
4
/6
Topic
ATMP
8
/10
Business development
2
CAR T
5
/8
Cell technology
8
/10
Cleanroom
4
/7
Clinical trials
2
Funding
1
GMP
8
/19
Management and training
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/3
Manufacturing
9
/14
Quality
8
/11
Regulations
15
/19
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Free
27
Paid
50
Free for members
9
Free, paid certificate
3
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PDA training courses
Multiple courses ranging from aseptic processing to biopharmaceuticals, cleaning, compounding, environmental monitoring, quality risk management system, lyophilization, parenteral packaging, etc
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GMP&GDP training courses
GMP and GDP
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GMP training courses
Aseptic production, microbiological quality control, quality assurance, pharmaceutical microbiology
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Clinical case studies on CART
CAR T case studies
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Drug development
Drug development (main focus is small molecules)
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Immuno-oncology
Tumor immunology, check point blockades, CAR T and other novel therapies
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Advanced Cell Therapy Technology
Apply detailed theoretical cell therapy process knowledge to upstream, cell expansion, and downstream applications. Identify bottlenecks and troubleshoot your specific processes. Perform industry standard techniques related to cell therapy manufacturing, with an emphasis on T-cell processes. Implement strategies used for process optimization and evaluation.
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Summerschool Advanced In Vitro Models
Best practices of advanced in vitro models, regulatory aspects, (stem) cell biology and technologies for testing medicine and/or substance safety testing as well as how the results can be validated, translated and implemented into human medicine
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Summerschool 3D Printing and Biofabrication
Basics of 3D printing, biofabrication and an insight into the challenges encountered when translating 3D printing towards biomedical applications
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Introduction To ATMPs/CGT
Basics of cell and gene therapy, practical working with various cell culture equipments
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Lab techniques in cell biology
Cell culture, cell counting and analysis, biobanking, sterility tests, transfection, image analysis
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Bioprocessing and Manufacturing of Gene and Cell Therapy Products Course
Basic knowedge about cell therapy, CART cells, dendritic cells (DC), mesenchymal stromal cells (MSCs), gene therapy, manufacturing and quality control, regulation and marketing, career coaching
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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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ATMP Manufacturing, From Process Development to the Patient
ATMP basic knowledge, auto vs. allo cell therapies, manufacturing steps, regulatory concepts closed vs open systems
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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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Summerschool Regenerative Medicine
Basics of regenerative medicine, stem cell biology and technologies as well as how this science is translated and implemented into patient care
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GMP summer school
Hands-on experience and knowledge in a real-world GMP setting
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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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Pharmaceutical Quality and Regulatory Affairs
manufacture, regulations and quality standards for the pharmaceutical and ATMP, GMP guidelines, Market access
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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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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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GMP e-learning trainings
GMP introduction, essentials, quality system
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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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Pharmaceutical Training
Multiple courses ranging from GxP, regulatory, QMS, auditor training, sterile and biotech and many more
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Deviations and CAPAs – Perform effective investigations
This one-day course focuses on the root cause analysis and impact assessment of deviations and the determination of appropriate corrective and preventive actions (CAPAs).
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Cleanroom behavior course
Product damage risks Particles: - Dust and germ development - Behavior - Fabric technology Man as a source of contamination - Clothing - Behaviour and discipline before and during presence in a clean room - Procedures, workplace control and communication Cleaning aspects
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HVAC/cleanrooms: ins and outs
HVAC system, measure flow profile and factors affecting the flow profile
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Cleanroom behavior course
Upon completion of the training, the participant is fully aware of the impact of the behaviour of staff working in cleanrooms, and how this behaviour may affect the quality of the product.
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Regulatory plans for ATMP
regulatory aspects of ATMP, difference between EU, US and canadian regulatory system
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