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Showing total 4 results
Start Over Topic european medicines agency Publication Year Range Last 3 years Journal pharmaceutical technology europe
4 results

1. Using RWD in Non-Interventional Studies: EMA is promoting the use of RWD in decision-making and has started a public consultation to review its draft recommendations.

Author

Barton, Cheryl

Subjects
HEALTH insurance reimbursement, SCIENTIFIC observation, DECISION making, DATA analytics, REPORTING of diseases, PHARMACEUTICAL industry, ACQUISITION of data, ELECTRONIC health records
Abstract

The article focuses on EMA's promotion of real-world data (RWD) in non-interventional studies for generating real-world evidence (RWE), addressing methodological aspects, governance, and data quality, aligning closely with FDA guidance but highlighting differences in NIS definitions, aiming to enhance regulatory decision-making and scientific rigor while improving transparency and reliability of industry-generated RWD.

Published
2024

2. European Medicines Agency Viewpoint.

Author

Spivey, Chris

Subjects
DRUG approval, INSTITUTIONAL cooperation, INVESTMENTS, VACCINES, INVENTORY shortages, HEALTH services administration, SOCIAL support, GOVERNMENT regulation, NEGOTIATION, CELLULAR therapy, MANUFACTURING industries, MEDICAL supplies, DRUG packaging, ORGANIZATIONAL goals, BUSINESS networks, HEALTH insurance reimbursement, SUPPLY chains, PATENTS, INTELLECTUAL property, DRUGS, INTERPROFESSIONAL relations, QUALITY assurance, GENE therapy, DRUG labeling, COMMUNICATION, PHARMACEUTICAL industry, COVID-19 pandemic, PUBLIC opinion, PSYCHOLOGICAL resilience, MEDICAL research
Abstract

The article focuses on insights provided by Steffen Thirstrup, the chief medical officer at the European Medicines Agency, regarding regulatory challenges and successes in Europe's pharmaceutical landscape. Topics discussed include the impact of the COVID-19 pandemic on regulatory agility, challenges and collaborations in drug pricing and reimbursement, and efforts to enhance supply chain resilience and proximity to manufacturing infrastructure.

Published
2024

3. EMA Guidance on Paediatric Investigation Plans: Stepwise paediatric investigation plans aim to boost the development of medicines for children.

Author

Barton, Cheryl

Subjects
PROFESSIONS, PHARMACEUTICAL technology, GOVERNMENT regulation, PEDIATRICS, MEDICAL protocols, DRUGS, HEALTH, INFORMATION resources, DRUG development, MEDICAL research, ADULT education workshops, MEDICAL societies
Abstract

The article focuses on the new European Union (EU) guidance for drug developers regarding the conduct of paediatric investigation plans (PIPs) issued by the European Medicines Agency (EMA) on February 6, 2023. It informs that the guidance was issued to address shortfall in paediatric regulation and improve harmonization of pedantic regulations.

Published
2023

4. Setting Goals for Sustainability: In light of increasingly stringent sustainability requirements, bio/pharma companies need to make sure they formulate effective ESG strategies.

Author

Thomas, Felicity

Subjects
SUSTAINABILITY, GOVERNMENT regulation, PHARMACEUTICAL industry, BUSINESS planning, GOAL (Psychology)
Abstract

The article discusses the increasing pressure on pharmaceutical companies to meet sustainability goals and objectives set by national governments and regulatory authorities. It explores the evolution of regulatory requirements related to drug development, marketing authorization, and monitoring set by the European Medicines Agency (EMA) and national pharmaceutical regulators. It further discusses the changes to supply chain regulations in Germany.

Published
2023