ICH Updates After Singapore Assembly Meeting

International – Guideline : General Principles for Planning and Design of Multi-Regional Clinical Trials...

Objectives of the Guideline With the increasing globalisation of drug development, it has become important that data from multi-regional clinical trials (MRCTs) can be accepted by...
EMA Takes Further Action in Ongoing Review of Tainted 'Sartans'

International – EMA Takes Further Action in Ongoing Review of Tainted ‘Sartans’

China's Zheijiang Huahai Pharmaceuticals (ZHP), the company at the center of the tainted valsartan crisis, will face increased scrutiny over other substances they produce,...
Top 9 Companies in the Diagnostics Market

International – Top 9 Companies in the Diagnostics Market

Add some market clearances; a rebranding; a merger or two; and some collaborations; and you’ve got a recipe for some of the most powerful...
Differences and similarities between FDA 21 CFR Part 820 and ISO 13485

International – Differences and similarities between FDA 21 CFR Part 820 and ISO 13485

ISO 13485:2016 is a voluntary standard for Quality Management Systems of medical device manufacturers and suppliers, and is used worldwide for developing and maintaining the...
FDA Seeks Comment on ICH Guideline on Optimizing Safety Data Collection

International – ICH Drafts Revised Guideline on General Considerations for Clinical Studies

With a focus on modernization, the International Council for Harmonisation (ICH) on Thursday released for public consultation a draft version of its guideline E8(R1)...
Biosimilar use may increase with scrutiny of high drug prices

International – Biosimilar use may increase with scrutiny of high drug prices

Complex biologic medications that are made in living cells are some of the most expensive drugs on the market, but expiring patents on biologics...
US FDA recognizes latest edition of ISO 14971 as medical device consensus standard

International – Improving Biosecurity with first International Standard for Biorisk Management

SARS, pandemic viruses and threats of the malicious use of pathogens have all woken the world up to the risks of biological materials and...
WHO Drafts Policy on Designating Regulators as Listed Authorities

International – WHO Stresses Role of GMP in Combatting Antimicrobial Resistance

The World Health Organization (WHO) issued a draft document Wednesday on environmental aspects of good manufacturing practices (GMP) to aid inspectors and manufacturers of...
Updated: US-EU Agreement on GMP Inspections Adds 5 More Member States

International – Updated: US-EU Agreement on GMP Inspections Adds 5 More Member States

The US Food and Drug Administration (FDA) earlier this month confirmed the capabilities of Belgium, Denmark, Finland, Estonia and Latvia so that FDA can...
Brexit Costs EMA Almost €60M in 2019

International – Two additional countries to benefit from EU-US mutual recognition agreement for inspections

In February 2019, the US Food and Drug Administration (FDA) confirmed the capability of two additional European Union Member States to carry out good manufacturing practice (GMP) inspections at...

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