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Showing 1 - 1 of 64 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
4
/6
Facility manager
24
/32
Patient representative
4
/6
Pharmacist
64
QA personnel
23
/29
QC personnel
21
Regulatory assurance expert
15
/20
Research nurse
2
/7
Scientist
63
/68
Technician
42
/44
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On Site
On Site
25
/35
Online
Online
33
/47
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0
/1
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Chinese
1
Dutch
16
/28
English
48
/62
Korean
1
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≤ 1 hour
14
/17
1 - 4 hours
9
/13
1 day
6
/7
4 - 8 hours
11
/17
Multi-day
19
/30
Varies per course
5
/6
Topic
ATMP
7
/10
Business development
1
/2
CAR T
2
/8
Cell technology
8
/10
Cleanroom
7
Clinical trials
2
Funding
1
GMP
15
/19
Management and training
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/3
Manufacturing
11
/14
Quality
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/11
Regulations
10
/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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GMP courses
GMP, GDP, quality risk management system
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GMP training courses
Aseptic production, microbiological quality control, pharmaceutical microbiology
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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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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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Multiples course about clean room monitoring and aseptic drug production
Aseptic production, microbiological quality control, pharmaceutical microbiology
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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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Aseptisch werken: de mindset die het verschil maakt
Basis microbiologie, de werking van een cleanroom, de verschillen tussen reinigen, desinfecteren, decontamineren en steriliseren, de verschillende soorten aseptische opstellingen (LAF, Biosafety, isolator, RABS), staalname en monitoring, persoonlijke hygiëne, aseptisch gedrag.
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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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Train-the-trainer in de Life Sciences
Training geven (on the job)
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GDP voor de Responsible Person (RP) in de Life Sciences
Good Distribution Practices
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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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Basis Bioprocessing
Hoe worden levende cellen ingezet als productiemiddel voor het maken van een nieuwe generatie aan geneesmiddelen en gezondheidsproducten.
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Basis GMP
Fundamentele wetmatigheden van de farmaceutische industrie
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Basis GMP voor ATMP productie
Fundamentele wetmatigheden van een ATMP productie
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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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Audit behaviour in de Life Sciences
Deelnemers krijgen praktische tools en do’s en dont’s aangereikt om effectief te communiceren met auditors.
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Computer System Validation (CSV) – van basics tot advanced
Definitie en belang van validatie, Data integrity, SCV, CSA
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Behandelen en schrijven van technische deviaties
Overzicht van hoe deviaties opgevolgd, onderzocht & gedocumenteerd kunnen worden
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