Post Authorization Safety Studies - Vaccines

Relevant Publications

Safety and efficacy evaluation of Simo decoction and in herbal medicine practice.

Issue Release: 2024

Comparison design and evaluation power in cohort and self-controlled case series designs for post-authorization vaccine safety studies.

Issue Release: 2024

Safety of mRNA COVID-19 vaccines among persons 15- years and above in Ghana: A cohort event monitoring study.

Issue Release: 2024

Adverse Reactions to Evolocumab: Analysis of Real-World Data from EudraVigilance.

Issue Release: 2024

Lessons learned from COVID-19, H1N1, and routine vaccine pharmacovigilance in the United States: a path to a more robust vaccine safety program.

Issue Release: 2024

Safety and reactogenicity of the BNT162b2 COVID-19 vaccine: Development, post-marketing surveillance, and real-world data.

Issue Release: 2024

Real-World Evidence to Support the Registration of a New Osteoporosis Medicinal Product in Europe.

Issue Release: 2024

Big Multiple Sclerosis Data network: an international registry research network.

Issue Release: 2024

Extracellular Vesicles as Next-Generation Diagnostics and Advanced Therapy Medicinal Products.

Issue Release: 2024

Real-world evidence study on the early use of cemiplimab in the UK: REACT-CEMI (Real World evidence of advanced CSCC treatment with cemiplimab).

Issue Release: 2024

CAR T cell resistance to oncogenic transformation.

Issue Release: 2024

Real-world non-interventional post-authorization safety study of long-term use of burosumab in children and adolescents with X-linked hypophosphatemia: first interim analysis.

Issue Release: 2024

Limitations Reported in Evaluating Effectiveness of Risk Minimization Measures in the EU during 2018-2021: A Qualitative Analysis of Industry-Sponsored Post-Authorization Safety Studies.

Issue Release: 2024

Case report: Envafolimab causes local skin necrosis.

Issue Release: 2024

Evaluation of the Regulatory Required Post-Authorization Safety Study for Propacetamol: Nested Case-Control and Case-Time-Control Studies.

Issue Release: 2024

Lessons learned from a multi-data source research collaboration: The mirabegron post-authorization safety study program.

Issue Release: 2024

Safety of 300IR house dust mite sublingual tablet from pooled clinical trial and post-marketing data.

Issue Release: 2024

Gene Therapy in Transfusion-Dependent Non-β0/β0 Genotype β-Thalassemia: First Real-World Experience of Beti-cel.

Issue Release: 2024

Harmonized Data Quality Indicators Maintain Data Quality in Long-Term Safety Studies Using Multiple Sclerosis Registries/Data Sources: Experience from the CLARION Study.

Issue Release: 2024

The Role of Real-World Data and Evidence in Oncology Medicines Approved in EU in 2018-2019.

Issue Release: 2023

Which Vaccines are Known to Reduce Antibiotic Use?

Why Is Herd Immunity Important?

What if My Child Misses a Dose?

What Can Individuals Do to Support the Initiative?

What are the Side Effects of the Tetanus Vaccine?

Why Are Vaccines Important for Diabetic Patients?

What Is Herd Immunity and How Does It Help?

Can Vaccines Overload the Immune System?

Why Are COVID-19 Vaccines Important?

What is the Future of T Cell-Based Vaccines?

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