EMA policy 0070 Relaunch in September 2023 – What you should need to know! 

Clinical Trial Regulation and EMA Policy 0070 restart

EMA Policy 0070 is to be relaunched in September 2023. This was announced by the European Medicines Agency during a webinar held on May 16, 2023.  All Marketing Authorization Holders who submit packages to EMA should immediately implement document anonymization processes.  EMA Policy 0070, which was originally implemented on January 1, 2015, has been around […]

Automation within Medical Writing

What does medical writing function do? Medical writing is a highly specialized field that involves content writing and clinical research on scientific documents of different types which include regulatory and research-related documents, disease or drug-related educational and promotional literature, periodicals, publication articles like journal manuscripts and abstracts, content for healthcare websites, health-related magazines, or news. […]

Synthetic Data Vs Real Data 

There has been an increase in interest in synthetic data over the past few years for various applications such as machine learning and data analytics. Research predicts that synthetic data will surpass real data by 2030. However, some executives and business leaders may not be familiar with the concept due to its differences from real […]

Data Protection 

The impact of globalization on privacy of identity is growing. The fact that more and more Data Protection, comprising data security and data privacy, has emerged as a major challenge in cross-border data flows means that data breaches often affect people in multiple countries and may result in financial frauds. Customers are demanding more security […]

ISMS Implementation 

Every technology-driven business process is exposed to security and privacy threats. Modern technologies are capable of preventing cybersecurity attacks, but these aren’t enough, organizations must ensure that business processes, policies, and workforce behaviour minimize or mitigate these risks.  What is an ISMS?  ISMS (ISO 27001) is an International Standard has been given by International Standards Organization (ISO) to […]

What is Password Protection?

Damanjeet Singh – Technical Lead- IT & Infrastructure Passwords provide the first line of defense against unauthorized access to your computer and personal information.   Once a password protects the data, only the person with the passwords will access the information or accounts.   Another user cannot read, change, or delete your data set without knowing the […]

What is KUBERNETES (k8s)? 

In this digital era, every project needs to be built in less time with more flexible and resilience manner.  Being a startup in pharmaceuticals, enterprises strive to innovate fast where team rolls out new feature, collects feedback from clients, and introduces changes until they find their product-market fit.   After covid – a global pandemic outbreak, […]

WHAT IS ISO CERTIFICATION AND WHY DOES IT MATTER?

Gurjeet Dhaunsi – Analyst- QA/CSV ISO (International Organization of Standardization) is non-profit organization which is setup with a goal to achieve standardization across global markets for same products in terms of consistency & quality. ISO was inaugurated in 1946 in London & today more than 24000 standards are in force, published by ISO in various […]

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