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ALLE LÄNDER (15)
1
FDA’s GMP Expectations for Phase I — FDA’s GMP Expectations for Phase I and First-in-Man Clinical Trials
08. Dez 2022 - 09. Dez 2022 • Washington DC, Vereinigte Staaten
Veranstalter:
FDAMap
Zusammenfassung:
Manufacturing an investigational product for the initial pilot clinical trials could pose a considerable logistical and financial challenge to developers. The first-in-man and pilot clinical trials are usually conducted in very small number of healthy participants with lower doses primarily to establish safety and hence do not need a significant amount of investigational material. The US FDA allows developers to test early stage investigational products under relaxed GMP requirements. The manufacturing requirements for early stage clinical trials are designed to assure adequate quality of the investigational product being tested without the excessive regulatory burden of full-scale GMP manufacturing. This workshop will present the current regulations, guidance documents and regulatory strategies available for manufacturing an early development stage product for Phase I and first-in-man clinical trials. Also discussed will be logistical issues with managing the supply of an early stage investigational product, and requirements for stability testing, storage and shipping, labeling, and documentations. Perspectives for different classes of products will be presented using case studies.
Themen:
Clinical Trials Clinical Studies Clinical Research GMP FDA Regulation FDA Compliance
Eintrags-ID:
1506292
2
Pre-Filled Syringes and Injectable Drug Devices Europe
10. Jan 2023 - 12. Jan 2023 • London, Großbritannien
Veranstalter:
SAE Media Group
Zusammenfassung:
The pre-filled syringes industry is growing at an exponential rate with innovations in parenteral delivery device development to increase patient centricity, aid self-administration and deliver biologics that have large-volumes and novel formulations. This year’s conference will explore the exciting advances in the combination product drug delivery space and a future outlook exploring how pharma, device developers and regulators can work together to encourage innovation.
Kontakt:
Tel.: [+44 (0) 20 7827 6086];     Email: rjones@smi-online.co.uk
Themen:
Pre-Filled Syringes, Injectable Drug Devices, drug development, regulatory guidelines, pharmaceutical industry, drug delivery, therapeutic sectors, vaccines, Parenteral administration, combination products, primary packaging, sterile injectables, connectivity, human factors, autoinjectors
Eintrags-ID:
1516213
3
Healthcare Basic Compliance Academy
03. Apr 2023 - 06. Apr 2023 • Nashville, TN , Vereinigte Staaten
Veranstalter:
Health Care Compliance Association (HCCA)
Eintrags-ID:
1526299
4
27th Annual Compliance Institute
23. Apr 2023 - 26. Apr 2023 • Anaheim, CA, Vereinigte Staaten
Veranstalter:
Health Care Compliance Association (HCCA)
Eintrags-ID:
1526298
5
Healthcare Basic Compliance Academy
08. Mai 2023 - 11. Mai 2023 • Chicago, IL, Vereinigte Staaten
Veranstalter:
Health Care Compliance Association (HCCA)
Eintrags-ID:
1526242
6
Healthcare Privacy Compliance Academy
08. Mai 2023 - 11. Mai 2023 • Chicago, IL, Vereinigte Staaten
Veranstalter:
Health Care Compliance Association (HCCA)
Eintrags-ID:
1526274
7
Healthcare Compliance Essentials Workshop
15. Mai 2023 - 18. Mai 2023 • Virtual, Vereinigte Staaten
Veranstalter:
Health Care Compliance Association (HCCA)
Eintrags-ID:
1526339
8
New Orleans Regional Healthcare Compliance Conference
19. Mai 2023 • Virtual, Vereinigte Staaten
Veranstalter:
Health Care Compliance Association (HCCA)
Eintrags-ID:
1526283
9
Research Compliance Conference
11. Jun 2023 - 13. Jun 2023 • Phoenix, AZ, Vereinigte Staaten
Veranstalter:
Health Care Compliance Association (HCCA)
Eintrags-ID:
1526337
10
SCCE's Creating Effective Compliance Training
21. Jun 2023 - 22. Jun 2023 • Virtual, Vereinigte Staaten
Veranstalter:
Health Care Compliance Association (HCCA)
Eintrags-ID:
1526314
11
Healthcare Basic Compliance Academy
24. Jul 2023 - 27. Jul 2023 • New Orleans, LA, Vereinigte Staaten
Veranstalter:
Health Care Compliance Association (HCCA)
Eintrags-ID:
1526302
12
Healthcare Basic Compliance Academy
21. Aug 2023 - 24. Aug 2023 • Washington, DC, Vereinigte Staaten
Veranstalter:
Health Care Compliance Association (HCCA)
Eintrags-ID:
1526301
13
Healthcare Privacy Compliance Academy
21. Aug 2023 - 24. Aug 2023 • Washington, DC, Vereinigte Staaten
Veranstalter:
Health Care Compliance Association (HCCA)
Eintrags-ID:
1526322
14
Healthcare Compliance Essentials Workshop
18. Sep 2023 - 21. Sep 2023 • Virtual, Vereinigte Staaten
Veranstalter:
Health Care Compliance Association (HCCA)
Eintrags-ID:
1526365
15
Healthcare Compliance Essentials Workshop
04. Dez 2023 - 07. Dez 2023 • Virtual, Vereinigte Staaten
Veranstalter:
Health Care Compliance Association (HCCA)
Eintrags-ID:
1526397


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Stand vom 29. November 2022