BLOGS BLOGS 28Nov November 28, 2023 How is EMA Addressing Medicine Shortages in Europe? 22Nov November 22, 2023 Kenya’s Systematic Approach to Pharmacovigilance 20Nov November 20, 2023 MHRA’s AI-Airlock for Safe Development of Medical Technologies 17Nov November 17, 2023 Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices 16Nov November 16, 2023 ISoP: The Need for Patient Engagement in Pharmacovigilance 07Nov November 7, 2023 AMDF: Ensuring the Safety of Donated Medical Devices 02Nov November 2, 2023 Japan PMDA: The Role of In-Country Clinical Caretakers 31Oct October 31, 2023 Regulatory Framework for Cosmetics in South Korea 27Oct October 27, 2023 Pharmacovigilance in Herbal and Alternative Medicine 19Oct October 19, 2023 Supporting Labelling Compliance with Searchable Databases 17Oct October 17, 2023 Swissmedic: The Importance of Real-World Evidence in Regulatory Decision Making 11Oct October 11, 2023 Modernization of Cosmetics Regulation Act 10Oct October 10, 2023 Ensuring Safe Use of Medical Devices in Healthcare Facilities 04Oct October 4, 2023 Evaluating the need for comparative clinical efficacy studies in biosimilar development 03Oct October 3, 2023 Prescription-Drug-Use-Related Software 28Sep September 28, 2023 Requesting Post-Warning Letter Meetings 20Sep September 20, 2023 UK MHRA International Recognition Procedure 14Sep September 14, 2023 Formal Meetings for Biosimilar Product Development with the US FDA 12Sep September 12, 2023 Paediatric Investigation Plan in Medicinal Product Development 05Sep September 5, 2023 Packaging Requirements for the Safety of Children 01Sep September 1, 2023 Post-market safety data for underrepresented populations in clinical trials 29Aug August 29, 2023 How to prepare for oral explanations with EMA 24Aug August 24, 2023 Guidance on Informed Consent in Clinical Investigations 22Aug August 22, 2023 Diversity Plan in Clinical Trials 17Aug August 17, 2023 US FDA: Enhancing the safety of cosmetic products 14Aug August 14, 2023 Overcoming challenges in determining AI limits for NDSRIs 10Aug August 10, 2023 Mandating CADIFA for drug registration in Brazil 04Aug August 4, 2023 CDER: Creating efficiencies in pharmaceutical development and manufacturing 28Jul July 28, 2023 The Impact of Artificial Intelligence in the Lifecycle of Medicines 25Jul July 25, 2023 Enhancing Accessibility to Contraceptives through Rx-to-OTC switch 18Jul July 18, 2023 The Future of Certificate of Suitability 14Jul July 14, 2023 ICH: An Approach to Harmonizing Real World Data & Real World Evidence 11Jul July 11, 2023 US FDA: Resolving Disputes for Over-the-Counter Monograph Drugs 05Jul July 5, 2023 US FDA: Safety Reporting Requirements for Combination Products 20Jun June 20, 2023 Challenges in Complex Generic Drug Development 16Jun June 16, 2023 US FDA: Keeping Up with the Momentum of Decentralized Clinical Trials 14Jun June 14, 2023 Evaluating PRIME: A Pathway for Innovative Medicines 08Jun June 8, 2023 Enhancing Good Clinical Practice for the Evolving Clinical Trial Landscape 06Jun June 6, 2023 How do Artwork Management Systems help maintain FDA compliance? 23May May 23, 2023 Drug-Device Products: Navigating through the EU 18May May 18, 2023 Indian Perspective on Digital Health Technology 12May May 12, 2023 Challenges With Medical Devices and Digital Health Technologies 10May May 10, 2023 Risk-Based Approach to Monitoring Clinical Trials 05May May 5, 2023 Digital Future of Healthcare 03May May 3, 2023 Regulatory Guidelines for Software and Artificial Intelligence as a Medical Device 28Apr April 28, 2023 WHO Pre-qualification pathway: advancing access to vaccines 26Apr April 26, 2023 DARWIN EU – Generating Real-World Evidence to Support Regulatory Decisions 21Apr April 21, 2023 Real-Time Remote Inspections – The New Normal 17Apr April 17, 2023 Rise of Digital Applications in the Healthcare Sector 11Apr April 11, 2023 Benefits of randomized control trials in accelerated approvals for oncology therapeutics 06Apr April 6, 2023 Maintaining compliance with Identification of Medicinal Products (IDMP) standards 04Apr April 4, 2023 Biosimilars uptake – An upward trend 15Mar March 15, 2023 Combination products: a regulatory perspective 10Mar March 10, 2023 Pre-market pathways for combination products 03Mar March 3, 2023 Mitigating medical device shortages in public health emergencies 28Feb February 28, 2023 Access to Orphan Drugs in Hereditary Angioedema 23Feb February 23, 2023 Digitalization in Regulatory Affairs 21Feb February 21, 2023 Medical Devices – Considerations for preparing a Clinical Evaluation Report (CER) 15Feb February 15, 2023 EU regulatory strategic goals for human medicines 10Feb February 10, 2023 Additional Risk Minimization Measures: Pregnancy Prevention Programme 08Feb February 8, 2023 Pharmacovigilance for Biosimilars vs pharmacovigilance for generics 03Feb February 3, 2023 An overview on pharmacovigilance in Japan, USA, Europe 01Feb February 1, 2023 What do you need to know about aggregate reporting? 25Jan January 25, 2023 Components of a risk management plan in pharmacovigilance 20Jan January 20, 2023 Social & Digital Media Sources in Drug Safety 17Jan January 17, 2023 Challenges in ICSR processing 12Jan January 12, 2023 Signal Management 12Jan January 12, 2023 Structured Product Labeling 03Jan January 3, 2023 Preparedness for inspections: Are you prepared for the upcoming pharmacovigilance inspection? 14Dec December 14, 2022 Enhancing medico-regulatory writing with artificial intelligence 12Dec December 12, 2022 Automation in Pharmacovigilance and Drug Safety 06Dec December 6, 2022 An overview on the analytical assessment techniques for biosimilar development 01Dec December 1, 2022 Challenges in immunogenicity assessments for biosimilar development 25Nov November 25, 2022 Differences in the regulatory pathways for biosimilar development: EU vs USA 22Nov November 22, 2022 US FDA draft guidance: Sameness Evaluations in an ANDA for active ingredients 17Nov November 17, 2022 A summary of the “Guidance on the licensing of biosimilar products”- UK MHRA 15Nov November 15, 2022 An overview on some key regulatory challenges in API manufacturing 18Oct October 18, 2022 Solutions and best practices in Publishing and submission management 17Oct October 17, 2022 Challenges in eCTD Publishing & Submission Management 12Oct October 12, 2022 Adalimumab as a treatment choice for Rheumatoid Arthritis- a pharmacoeconomic perspective 03Oct October 3, 2022 European Medicines Agency: Biosimilar medicines can be interchanged 29Sep September 29, 2022 Overview on Cardiovascular Medical Device Regulation by the FDA 26Sep September 26, 2022 Increasing access to contraceptive implants for better and safe family planning 16Sep September 16, 2022 ICSR PROCESSING & PATIENT SAFETY 15Sep September 15, 2022 Pharmacovigilance Services at DDReg: Our commitment towards Patient Safety 14Sep September 14, 2022 Medication errors: Self-medication 01Sep September 1, 2022 Understanding the EU Clinical Trial Information System 24Aug August 24, 2022 Treating Clostridium difficile infections using biotherapeutics 08Aug August 8, 2022 Why is an ISO 27001 important for an organization? 28Jul July 28, 2022 Regulatory Information Management Systems (RIMS) 20Jul July 20, 2022 Role of Regulatory Affairs in the Pharmaceutical Industry 15Jul July 15, 2022 India’s New Drugs, Medical Devices and Cosmetics Bill 2022 28Jun June 28, 2022 Quality Management Maturity Program by the CDER of the U.S. FDA 14Jun June 14, 2022 Outsourcing regulatory compliance solutions 29Apr April 29, 2022 Is QPPV training essential?