Regulatory Affairs and Compliance
Advanced Program in Pharmaceutical Quality Management
Encompassing ICH, WHO, FDA and Quality 4.0 Requirements and Best Industry Practices
India is the worlds third largest pharmaceutical generics producer with the highest number of FDA and MHRA GMPapproved manufacturing plants outside the US and Europe The challenge of remaining in GMP compliance continues to be the main concern India has seen a resurgence of breach of data integrity and quality issues
PHAMACEUTICAL PROMOTION MATERIAL
GLOBAL LAWS OVERVIEW
One of the most important tasks of any regulatory body is to ensure that pharmaceutical products are developed in accordance with the localregional regulatory requirements
Developing a Robust Contamination Control Strategy
Ecolab’s approach
As most readers will be aware Annex of EudraLex Volume GMPs is being updated The process has been somewhat protracted with multiple versions being reviewed updated and discardedAs most readers will be aware Annex of EudraLex Volume GMPs is being updated The process has been somewhat protracted with multiple versions being reviewed updated and d...
Pre-Inspection Audits Can Help You Prepare for Regulatory Inspections
Prepare For The Return of Regulatory Inspections
Regulatory authority inspections are restarting across the world Companies can help ensure that they are ready for these inspections by utilising third party specialists to audit their facilities NSF Internationals team of exFDA MHRA and other regulatory body inspectors along with our experienced industry specialists are currently working with comp...
An Overview of Clinical Overview
A Clinical Overview is an integrated document intended to provide critical analysis of Pharmacology Efficacy and Safety of the pharmaceutical agent in humans It is one of the important documents of Module of the Common Technical Document CTD ie Module which refers to the data provided in the comprehensive clinical summary the individual clinical...
Brexit and Pharmacovigilance
Where may pharmaceutical companies go?
What may happen to sick people should medicinal products suddenly not be available owing to Brexit Some million patient packs go to the European Union EU from the United Kingdom UK every month with a further million patient packs moving from the EU to the UK
Understanding Bio-summary Tables for ANDA Submissions
Biosummary tables also known as Division of Bioequivalence DBE Tables are one of the main prerequisites for Module submitted to the United States Food and Drug Administration US FDA as a part of the eCTD dossier
Innovation in pharmacovigilance
Where does Israel stand and ISOP ISRAEL role?
The Israeli pharmacovigilance system was founded recently All over the world pharmacovigilance regulations have evolved mainly from lessons learned as a reaction to safety issues that became public health issues
Strategic Partnerships and External Innovation
The last years have seen tremendous changes in the pharmaceutical industry The significant amount of public and private investment made into sequencing the genome have brought about some important medical and scientific advances However these advances have not resulted in
