<iframe src="https://www.googletagmanager.com/ns.html?id=GTM-WR9VRVQ" height="0" width="0" style="display:none;visibility:hidden">

thought leadership

ProPharma’s team of dedicated experts is at the forefront of both existing and emerging industry trends. ProPharma’s team inspires tomorrow by leveraging rich data insights across our service lines and functional areas to develop innovative solutions that answer the most complex needs of both existing and prospective clients.

EMA Clinical Research Solutions

September 5, 2023

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...

EMA Regulatory Sciences

August 3, 2023

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...

EMA EU

April 13, 2023

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...

EMA Europe

August 23, 2022

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...

North America EMA

August 22, 2022

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...

EMA Europe

August 19, 2022

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...

EMA Europe

August 10, 2022

EMA COVID-19 guidance: research and development

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...

FDA MHRA

August 8, 2022

Early engagement with Health Technology Assessment authorities will accelerate product launch and improve chances for reimbursement

Pharmaceutical companies should understand EU Health Technology Assessment (HTA) authorities requirements early in the product development phase. Engagement with HTA authorities during clinical...

EMA Europe

August 3, 2022

EMA: List of centrally authorised products requiring a notification of a change for update of annexes

August 2022 EMA Regulatory and Procedural Guideline Parallel distributors are only required to inform the EMA of changes to the labelling or leaflet related to any update of the annexes of marketing...

Prev 1 2 3 4 Next

Inspiring the Future of Drug Development

We’ve developed a process that suits the today’s needs and a better experience for clients. Our industry is constantly changing. Let us help you accelerate your innovation.