166 results on '"Gruber, Marion"'
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2. 6 Meeting Regulatory Criteria and Seeking Licensure: Medicines Development Before and During Public Health Emergencies
3. Enabling the evaluation of COVID-19 vaccines with correlates of protection
4. Contributors
5. Current status of monkeypox vaccines
6. Designing for Context-Aware and Contextualized Learning
7. Considerations in boosting COVID-19 vaccine immune responses
8. Report of the second international conference on next generation sequencing for adventitious virus detection in biologics for humans and animals
9. Mobile Blended Learning
10. Evaluating human trials : FDA’s role
11. Designing for Context-Aware and Contextualized Learning
12. Clinical Development Strategies and Considerations for Zika Vaccine Licensure
13. Detection of bovine viral diarrhoea virus nucleic acid, but not infectious virus, in bovine serum used for human vaccine manufacture
14. Beyond Delivery Modes and Apps: A Case Study on Mobile Blended Learning in Higher Education
15. Approaches to demonstrating the effectiveness of filovirus vaccines: Lessons from Ebola and COVID-19
16. Enabling the evaluation of COVID-19 vaccines with correlates of protection.
17. Flexibel in neuen Kontexten lernen
18. Contributors
19. Regulation and Testing of Vaccines
20. Regulatory considerations in the clinical development of vaccines indicated for use during pregnancy
21. Global and National Initiatives to Facilitate Studies of Vaccines in Pregnant Women
22. Standardization of Game Based Learning Design
23. Making more COVID-19 vaccines available to address global needs: Considerations and a framework for their evaluation
24. Orchestrating Learning Using Adaptive Educational Designs in IMS Learning Design
25. Chapter 80 - Regulation and Testing of Vaccines in the US
26. Clinical Evaluation of Pertussis Vaccines: US Food and Drug Administration Regulatory Considerations
27. We don't need universal booster shots. We need to reach the unvaccinated
28. Overview of global regulatory toxicology requirements for vaccines and adjuvants
29. Meeting report: CEPI consultation on accelerating access to novel vaccines against emerging infectious diseases for pregnant and lactating women, London, 12–13 February 2020
30. Beyond Delivery Modes and Apps: A Case Study on Mobile Blended Learning in Higher Education
31. Licensing of Pneumococcal Conjugate Vaccines for Children and Adults: Regulatory Perspective from the European Medicines Agency and the U.S. Food and Drug Administration
32. SARS-CoV-2 Variants and Vaccines
33. Evolving pharmacovigilance requirements with novel vaccines and vaccine components
34. The US FDA pregnancy lactation and labeling rule – Implications for maternal immunization
35. Nonclinical Testing of Vaccines: Report from a Workshop
36. Emergency Use Authorization of Covid Vaccines — Safety and Efficacy Follow-up Considerations
37. Perspectives in risk assessment—Drug and vaccine safety
38. Standardization of Game Based Learning Design
39. Orchestrating Learning Using Adaptive Educational Designs in IMS Learning Design
40. Influenza immunization during pregnancy: US regulatory perspective
41. US FDA review and regulation of preventive vaccines for infectious disease indications: impact of the FDA Amendments Act 2007
42. Global harmonization of vaccine testing requirements: Making elimination of the ATT and TABST a concrete global achievement
43. List of contributors
44. Regulatory considerations in the nonclinical safety assessment of adjuvanted preventive vaccines
45. Principles of Risk Assessment — FDA Perspective
46. Flexibel in neuen Kontexten lernen
47. 79 - Regulation and Testing of Vaccines
48. Maternal immunization: US FDA regulatory considerations
49. Evaluating human trials: FDA's role
50. Entdeckerlust - Burgdorfer Sammlerpersönlichkeiten und ihre ostasiatischen Schätze
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