whitepaper
Whitepaper: Combining rapid and EP bioburden testing
A combined testing procedure to overcome the manufacturing bottleneck caused by the time needed for compendial bioburden testing according to EP.
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Regulation & Legislation
whitepaper
Whitepaper: SARS-CoV-2 vaccines and biosafety
Upholding biosafety standards in coronavirus vaccine development and manufacturing despite the acute worldwide need.
news
EMA and HMA publish joint strategy on medicine regulation for next five years
The EMA and HMA have published their joint strategy for the next five years, detailing how the regulatory network can continue the supply of safe and effective medicines.
whitepaper
Fact sheet: 5 Secrets to a successful cleaning validation program
Here are five ways to ensure a successful and compliant cleaning validation program.
article
Consistent data matters: lessons from the pandemic and the case for accelerating IDMP adoption
As ISO IDMP data standards gradually progress to implementation in Europe, Lise Stevens asks what bearing they might have had in the context of the global COVID-19 crisis.
whitepaper
Whitepaper: Tips to improve SEC for mAbs and ADCs
Practical Tips for Monomer/Aggregate and Fragment Content Monitoring of monoclonal antibodies (mAbs) and antibody-drug conjugates (ADCs).
whitepaper
Whitepaper: Single-use systems underline the rising significance of extractables and leachables studies
Single-use systems come with their own extractables and leachables challenges. Although there are no formal guidelines yet, safety must be assessed.
whitepaper
iPDF: Pharma analysis & QC interactive detailed workflow
Secure your Pharma analysis & QC - Take your journey through our small molecules and biologics analysis & QC regulatory compliant portfolio.
news
EMA begins rolling review of Janssen’s COVID-19 vaccine candidate
The European Medicines Agency's CHMP has started a rolling review of Ad26.COV2.S, Johnson & Johnson's COVID-19 vaccine.
news
Moderna applies for regulatory authorisation for COVID-19 vaccine
The company has submitted for Emergency Use Authorization in the US and Conditional Marketing Authorization in Europe for its mRNA-1273 vaccine against COVID-19.
article
Regulatory response to the COVID-19 pandemic
Dr Ash Ramzan, founder and principal consultant at Woodley BioReg, discusses how the COVID-19 pandemic has forced regulatory processes to adapt, focusing on the regulatory flexibilities introduced by the UK’s MHRA.
news
MHRA approves Pfizer and BioNTech COVID-19 vaccine
The UK's MHRA has given temporary emergency authorisation to Pfizer and BioNTech's COVID-19 vaccine, making it the first in the world to receive approval.
news
EC approves Dupixent for children aged six to 11 to treat severe atopic dermatitis
The EC has approved an extension of marketing authorisation for Regeneron and Sanofi's Dupixent (dupilumab) for children aged six to 11 with severe atopic dermatitis.
news
Pfizer and BioNTech submit for EU marketing authorisation for COVID-19 vaccine
If the Conditional Marketing Authorization application is approved, the COVID-19 vaccine BNT162b2 could be used in the EU by the end of 2020.
news
EMA highlights link between hydroxychloroquine and psychiatric disorders
The EMA recommends updating the product information for chloroquine and hydroxychloroquine after confirming a link between these medicines and psychiatric disorders.
