ema

Regulatory Sciences

How to Create Successful Pricing and Reimbursement of your Pharmaceutical Product in the Nordics

Our Nordic region features world-class healthcare. Understanding the Nordic healthcare and market access landscape is crucial for successful pricing and reimbursement of your pharmaceutical product....

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Medical Information

Enhancing Animal Health Compliance with Comprehensive Medical Information (MI) and Pharmacovigilance (PV) Services

Comprehensive Animal Health Medical Information (MI) and Pharmacovigilance (PV) support services in the veterinary industry are a must-have for companies who want to ensure the safety, efficacy, and...

Healthcare providers pointing to a tablet device

Regulatory Sciences

UK/EU Regulatory Developments Review 2023

Introduction The year 2023 has been remarkable in terms of regulatory developments within the UK and EU, characterised by substantial changes, innovative approvals, and strategic initiatives in the...

EU Flags outside building

Clinical Research Solutions

Navigating Expedited Regulatory Pathways in Europe: The Latest Insights and Advancements

Are you truly up to speed on the most effective strategies to expedite the approval process for your innovative product in Europe's evolving regulatory landscape? In the United States (US), the Food...

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Clinical Research Solutions

EMA Policy 0070: Back on the Road to Transparency

By now, most involved in the clinical trials disclosures field are aware of the upcoming reinstatement of the European Medicine Agency's (EMA) landmark transparency regulation: Policy 0070. Policy...

Gloved hands writing on clipboard and holding a petri dish

Clinical Research Solutions

Integrity and Reliability Concerns in Bioequivalence Studies: An Insight into the Synapse Labs Inspection

In a globalized pharmaceutical industry, ensuring the integrity and reliability of clinical data is of utmost importance. Recently, the Spanish Medicines Agency conducted a comprehensive Good...

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Clinical Research Solutions

EMA’s Regulatory Science Strategy to 2025 is on Track

Key messages from the mid-point achievements report To strengthen regulatory and scientific support for innovative medicines and diagnostics development, in March 2020 EMA published its Regulatory...

Magnified cells of monkeypox or mpox.

Clinical Research Solutions

EMA: Monkeypox

The European Medicines Agency (EMA) is supporting the European Union's (EU) response to the monkeypox outbreak. It is in close contact with medicine developers and its partner organisations in the EU...

Clinical Research Solutions

Orphan Designation of ATMPs for Rare Diseases: MPS II Case Study

Orphan Designation of ATMPs for Rare Diseases: MPS II Case Study Many advanced therapy medicinal products (ATMPs) in development in the EU are for rare diseases and conditions. Since the...

Clinical Research Solutions

EMA’s Emergency Task Force advises on intradermal use of Imvanex / Jynneos against monkeypox

August 19, 2022 EMA’s Emergency Task Force (ETF) has reviewed data on the monkeypox vaccine Imvanex 1 used as an intradermal injection (given just below the top layer of the skin). The vaccine is...

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