BLOGS
BLOGS
November 28, 2023
How is EMA Addressing Medicine Shortages in Europe?
November 22, 2023
Kenya’s Systematic Approach to Pharmacovigilance
November 20, 2023
MHRA’s AI-Airlock for Safe Development of Medical Technologies
November 16, 2023
ISoP: The Need for Patient Engagement in Pharmacovigilance
November 7, 2023
AMDF: Ensuring the Safety of Donated Medical Devices
November 2, 2023
Japan PMDA: The Role of In-Country Clinical Caretakers
October 31, 2023
Regulatory Framework for Cosmetics in South Korea
October 27, 2023
Pharmacovigilance in Herbal and Alternative Medicine
October 19, 2023
Supporting Labelling Compliance with Searchable Databases
October 11, 2023
Modernization of Cosmetics Regulation Act
October 10, 2023
Ensuring Safe Use of Medical Devices in Healthcare Facilities
October 3, 2023
Prescription-Drug-Use-Related Software
September 28, 2023
Requesting Post-Warning Letter Meetings
September 20, 2023
UK MHRA International Recognition Procedure
September 14, 2023
Formal Meetings for Biosimilar Product Development with the US FDA
September 12, 2023
Paediatric Investigation Plan in Medicinal Product Development
September 5, 2023
Packaging Requirements for the Safety of Children
August 29, 2023
How to prepare for oral explanations with EMA
August 24, 2023
Guidance on Informed Consent in Clinical Investigations
August 22, 2023
Diversity Plan in Clinical Trials
August 17, 2023
US FDA: Enhancing the safety of cosmetic products
August 14, 2023
Overcoming challenges in determining AI limits for NDSRIs
August 10, 2023
Mandating CADIFA for drug registration in Brazil
July 18, 2023
The Future of Certificate of Suitability
June 20, 2023
Challenges in Complex Generic Drug Development
June 14, 2023
Evaluating PRIME: A Pathway for Innovative Medicines
May 23, 2023
Drug-Device Products: Navigating through the EU
May 18, 2023
Indian Perspective on Digital Health Technology
May 10, 2023
Risk-Based Approach to Monitoring Clinical Trials
May 5, 2023
Digital Future of Healthcare
April 28, 2023
WHO Pre-qualification pathway: advancing access to vaccines
April 21, 2023
Real-Time Remote Inspections – The New Normal
April 17, 2023
Rise of Digital Applications in the Healthcare Sector
April 4, 2023
Biosimilars uptake – An upward trend
March 15, 2023
Combination products: a regulatory perspective
March 10, 2023
Pre-market pathways for combination products
February 28, 2023
Access to Orphan Drugs in Hereditary Angioedema
February 23, 2023
Digitalization in Regulatory Affairs
February 15, 2023
EU regulatory strategic goals for human medicines
February 10, 2023
Additional Risk Minimization Measures: Pregnancy Prevention Programme
February 8, 2023
Pharmacovigilance for Biosimilars vs pharmacovigilance for generics
February 3, 2023
An overview on pharmacovigilance in Japan, USA, Europe
February 1, 2023
What do you need to know about aggregate reporting?
January 25, 2023
Components of a risk management plan in pharmacovigilance
January 20, 2023
Social & Digital Media Sources in Drug Safety
January 17, 2023
Challenges in ICSR processing
January 12, 2023
Signal Management
January 12, 2023
Structured Product Labeling
December 14, 2022
Enhancing medico-regulatory writing with artificial intelligence
December 12, 2022
Automation in Pharmacovigilance and Drug Safety
December 1, 2022
Challenges in immunogenicity assessments for biosimilar development
November 15, 2022
An overview on some key regulatory challenges in API manufacturing
October 18, 2022
Solutions and best practices in Publishing and submission management
October 17, 2022
Challenges in eCTD Publishing & Submission Management
September 29, 2022
Overview on Cardiovascular Medical Device Regulation by the FDA
September 16, 2022
ICSR PROCESSING & PATIENT SAFETY
September 15, 2022
Pharmacovigilance Services at DDReg: Our commitment towards Patient Safety
September 14, 2022
Medication errors: Self-medication
September 1, 2022
Understanding the EU Clinical Trial Information System
August 24, 2022
Treating Clostridium difficile infections using biotherapeutics
August 8, 2022
Why is an ISO 27001 important for an organization?
July 28, 2022
Regulatory Information Management Systems (RIMS)
June 14, 2022
Outsourcing regulatory compliance solutions
April 29, 2022