Medical Information
Medical Information services are essential to ensure healthcare professionals (HCPs), patients, and regulatory bodies receive accurate, timely, and compliant information. From managing inquiries to...
Regulatory Sciences
The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have recently concluded a successful pilot project on electronic product information (ePI), marking a significant...
Regulatory Sciences
The HTAR in the EU has come into force – what Health Technology Developers (HTDs) need to know Getting your health technology product to the market is complex and usually consists of several steps...
Regulatory Sciences
The pharmaceutical industry has shown a growing interest in single-arm trials due to their potential to expedite drug development. However, several challenges and concerns remain. The European...
Regulatory Sciences
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....
Pharmacovigilance
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...
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...
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...
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...
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...
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...
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...
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...
The European Medicines Agency (EMA) provides support to medicine developers researching and developing potential COVID-19 medicines. Dedicated guidance, rapid procedures and contact points are...
Pharmaceutical companies should understand EU Health Technology Assessment (HTA) authorities requirements early in the product development phase. Engagement with HTA authorities during clinical...
Regulatory Sciences
If a marketing authorisation is planned to be submitted in England, Scotland, and Wales (GB), an MHRA-approved paediatric investigational plan (PIP) is required. Up until January 1, 2021, PIPs were...