Clinical Research Solutions
EMA: Big data use for public health: publication of Big Data Steering Group workplan 2022-25
News July 28, 2022 The Big Data Steering Group set up by EMA and the Heads of Medicines Agencies (HMA) has published its third workplan that sets key actions to be delivered between 2022–25. The new...
Clinical Research Solutions
How to Fast-Track medicine approval in the UK with the MHRA’s Innovative Licensing and Access Pathway (ILAP)
What is ILAP? What benefits does ILAP provide? How do you access it? With the dust of Brexit settling, the question on most people’s lips (well, those of us in the healthcare sector anyway!) was:...
Clinical Research Solutions
5 Benefits of Receiving EU PRIME Designation for Medicine Developers
What it is, why it matters, how you can apply and how we can help. What is the PRIME Scheme? You might be forgiven if you don’t know what the PRIority MEdicines (PRIME) scheme is; but if you are in...
Clinical Research Solutions
EMA Good clinical practice (GCP) inspection procedures
The Good Clinical Practice (GCP) Inspectors Working Group has developed procedures for the coordination, preparation, conduct and reporting of GCP inspections requested by the European Medicines...
Clinical Research Solutions
Orphan Drug Designations in the US and EU
What is an Orphan Drug Designation? The Orphan Drug Designation (ODD) program in both the United States (U.S.) and European Union (E.U.) qualifies sponsors to receive potential incentives to develop...
Clinical Research Solutions
Global regulators agree on key principles on adapting vaccines to tackle virus variants
News 01/07/2022 On 30 June, regulators from around the world discussed emerging evidence to support adaptation of COVID-19 vaccines as the SARS-COV-2 virus continues to evolve during a workshop...
Clinical Research Solutions
Clinical Pharmacology Considerations for Oligonucleotides
For the first time, the FDA has issued a draft guidance for industry on “Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics”. Oligonucleotides are short single...
Clinical Research Solutions
How to Leverage EMA’s ATMP Classification
Advanced therapy medicinal products (ATMPs) have emerged as ground-breaking therapies for rare diseases and other conditions with unmet clinical needs. As of 2022, sixteen ATMPs have been approved by...
Clinical Research Solutions
Maximising on Scientific Advice Procedures in Europe
A unique opportunity to interact with medicine regulators in Europe Are you considering requesting scientific advice in Europe? We can help you navigate the various procedures within the European...
Clinical Research Solutions
EMA adopts first list of critical medicines for COVID-19
News On 7 June 2022, EMA's Medicines Shortages Steering Group (MSSG) adopted the list of critical medicines for the COVID-19 public health emergency. The medicines included in the list are authorised...