Articles & Video
The Future of the Global Pharmaceutical Regulatory Affairs Industry
In a new interactive ebook, we take a deep dive into the challenges and trends we may see in pharmaceutical regulatory affairs over the next decade.
Pharma and Medical Device Regulations Content Library: Whitepapers and Reports Collection
Explore our collection of exclusive whitepapers and reports covering the hottest topics in pharma, biotech and medical device regulatory affairs and law with one simple registration.
Post-event Report: Global Pharmaceutical Regulatory Affairs Summit 2020
This report takes a detailed look back at the 2020 virtual Global Pharmaceutical Regulatory Affairs Summit.
What is standing in the way of global harmonisation?
Despite many efforts to globalise the pharmaceutical market, why are regulatory affairs still a challenge for drug manufacturers? Figen Kabadas highlights the obstacles.
Regulations in Brazil: What the drug approval process is like in 2020
How has Brazil and LATAM adapted pharmaceutical regulations according to COVID-19 and harmonisation with other regions?
Barriers and Challenges for Global Regulatory Harmonization
What obstacles are keeping regions such as Latin America from achieving regulatory harmonization with the rest of the world?
Oligonucleotides and peptides: the regulatory challenges
We investigate where current regulatory obstacles lie surrounding peptide and oligonucleotide therapeutics.
Brazil & LATAM Pharmaceutical Regulations: Global Harmonisation & the Impact of Covid-19
We speak to two industry experts about how Brazil and LATAM region is working toward global regulatory harmonisation.
The Future of IDMP: Quick Fire Questions with the Experts
We spoke to five experts from across regulatory information management about IDMP, the impact of COVID-19 and common obstacles.
Global Pharmaceutical Regulatory Affairs Digital Week offers live practical advice
From future RIM to implementing IDMP, we take a first look at the insightful sessions of the new webinar series coming 24 June.
COVID-19: Advice from the legal experts
We asked legal experts for their best tips and advice for pharmaceutical organisations during the COVID-19 pandemic.
Industry Report: Global Pharmaceutical Regulatory Affairs 2020
From data handling to language barriers, our latest report reveals the challenges pharma professionals are facing in regulatory processes around the world today.
The use of Real World Evidence and AI within the regulatory landscape
This whitepaper explores how the pharmaceutical industry can leverage Real World Evidence and AI in regulatory affairs.
Building a global regulatory strategy
This whitepaper identifies the key factors, requirements and challenges affecting applying for marketing authorisation in different world regions.
Global Pharmaceutical Regulatory Affairs State of the Industry Report 2019
In early 2019, we surveyed the perspectives of pharmaceutical regulatory professionals around the world. This report reveals insights into the industry's greatest challenges.
China's changing pharmaceutical regulatory approval landscape
China has recently taken unprecedented steps to improve its healthcare and regulatory system. This whitepaper examines the recent changes and what opportunities and challenges they bring.
Regulatory challenges and strategies for oligonucleotide, peptide and mRNA therapeutics - WHITEPAPER
We explore the regulatory challenges and successful approval strategies for oligonucleotide, peptide and mRNA therapeutics.
Regulatory development opportunities for global harmonisation of eSubmissions
What's delaying the global harmonisation of eSubmissions for market authorisation? This whitepaper examines the latest developments and ongoing challenges.