DDReg Pharma

DELIVER BETTER DATA TO ENSURE FASTER APPROVAL

An overview on pharmacovigilance in Japan, USA, Europe

What do you need to know about aggregate reporting?

Components of a risk management plan in pharmacovigilance

Social & Digital Media Sources in Drug Safety

Challenges in ICSR processing

Signal Management

Structured Product Labeling

Preparedness for inspections: Are you prepared for the upcoming pharmacovigilance inspection?

Enhancing medico-regulatory writing with artificial intelligence

Automation in Pharmacovigilance and Drug Safety

Convergence of regulatory frameworks surrounding cell, tissue, and gene therapy products

An overview on the analytical assessment techniques for biosimilar development

Challenges in immunogenicity assessments for biosimilar development

Differences in the regulatory pathways for biosimilar development: EU vs USA

US FDA draft guidance: Sameness Evaluations in an ANDA for active ingredients

A summary of the “Guidance on the licensing of biosimilar products”- UK MHRA

An overview on some key regulatory challenges in API manufacturing

Solutions and best practices in Publishing and submission management

Challenges in eCTD Publishing & Submission Management

Adalimumab as a treatment choice for Rheumatoid Arthritis- a pharmacoeconomic perspective

European Medicines Agency: Biosimilar medicines can be interchanged

Overview on Cardiovascular Medical Device Regulation by the FDA

Increasing access to contraceptive implants for better and safe family planning

ICSR PROCESSING & PATIENT SAFETY

Pharmacovigilance Services at DDReg: Our commitment towards Patient Safety

Medication errors: Self-medication

Understanding the EU Clinical Trial Information System

Treating Clostridium difficile infections using biotherapeutics

DDReg receives the ISO 27001:2013 certification for Information Security Management System

Why is an ISO 27001 important for an organization?

Regulatory Information Management Systems

Role of Regulatory Affairs in the Pharmaceutical Industry

India’s New Drugs, Medical Devices and Cosmetics Bill 2022

DDReg celebrates its 13th Foundation Day

Quality Management Maturity Program by the CDER of the U.S. FDA

Technological transformation in Pharmacovigilance

Outsourcing regulatory compliance solutions

DDReg attends National Conference on Pharmacovigilance and Clinical Research 2022- Chandigarh College of Pharmacy

Nanobodies vs antibodies in the fight against Covid

Enhancing drug discovery processes through artificial intelligence

DDReg to participate in CPhI North America conference in Philadelphia from 17th-19th May, 2022

Is QPPV training essential?

The impact of the Russia-Ukraine war on clinical trials

The first global centre for traditional medicine: WHO Global Centre for traditional medicine in Gujurat, India

DDReg’s RegTech space: your regulatory solution for achieving rapid market access

DDReg Pharma: Silver Sponsors of the 7th GCC Pharma Summit 2022, Dubai, UAE

Biologics development & regulatory approval – EMA perspective

Biosimilarity and Interchangeability in the MENA region

DDReg enters into RegTech Space

Biosimilars in the Emerging World

African Medicines Agency

Integrative Medicine

Knowledge Management in Regulatory Affairs (KMRA)

Telehealth – Regulatory Perspective

Expanded use of RWE (Real World Evidence)

Artificial Intelligence – Impact on The Global Pharma Industry

Identification of Medicinal Products (IDMP) – The Perspective of US FDA & EMA

Controlled Correspondence with FDA – An Update

Generic Drug User Fee Amendments

Impact of Brexit on the Pharmaceutical Industry

Nitrosamine Impurities: A Regulatory Perspective