Meet us BLOGS Meet Us BLOGS 24Apr April 24, 2024 Conducting Clinical Trials for Investigational Products in Brazil 22Apr April 22, 2024 Controlled Correspondence for Generic Drug Development 18Apr April 18, 2024 CMC Considerations for Human Gene Therapy INDs 17Apr April 17, 2024 Commitment to Biological Product and Patient Safety in India 15Apr April 15, 2024 Empowering Rare Disease Drug Developers 08Apr April 8, 2024 How is Team AB Gearing up for the new MedTech Legislation? 01Apr April 1, 2024 Harmonization for the Development of Cell and Gene Therapies 28Mar March 28, 2024 Essential Aspects of Labeling for Clinical Supplies and Investigational Products 26Mar March 26, 2024 Assessing COVID-19 Symptoms in Clinical Trials 20Mar March 20, 2024 Asserting Patient Rights: The Importance of Labels for Medical Device Traceability 13Mar March 13, 2024 Submitting Revised ANDA Labels to Ensure Safety & Compliance 04Mar March 4, 2024 Development of CAR T Cell Products 27Feb February 27, 2024 Model-Integrated Evidence Program for Generic Drugs 22Feb February 22, 2024 Searchable Databases for Bio-Equivalence Guidance 14Feb February 14, 2024 Increasing Harmonization for Complex Generics 12Feb February 12, 2024 Strengthening Safety Compliance in Somalia 08Feb February 8, 2024 Ensuring Viral Safety of Biotechnology Products 05Feb February 5, 2024 Regulatory Roadmap for Access to MedTech 02Feb February 2, 2024 Fostering Medical Innovation with Expedited Review Processes 29Jan January 29, 2024 Easing Requirements for Minimal Risk Clinical Trials 25Jan January 25, 2024 Standardizing Real World Data for Drug and Biological Product Submissions 23Jan January 23, 2024 Streamlining Clinical Investigations for Medical Devices 18Jan January 18, 2024 Third Party Review Program for Medical Devices 15Jan January 15, 2024 SwissMedic: Strengthening Safety Signal Reporting for Veterinary Products 11Jan January 11, 2024 Effective Communication for the Safe Use of Biosimilars 08Jan January 8, 2024 Indian Pharmacopoeia Commission: Safety Alert for Mefenamic Acid 05Jan January 5, 2024 The Use of Item Response Theory in Clinical Outcome Assessments 03Jan January 3, 2024 Enhancing Medical Device Cybersecurity 02Jan January 2, 2024 Utilizing Real-World Evidence for Medical Devices 21Dec December 21, 2023 Reforming ANDA Suitability Petitions 19Dec December 19, 2023 Online Eligibility Checker Tool for International Recognition Procedure 15Dec December 15, 2023 UK MHRA: Navigating Nuances in Clinical Trial Applications 12Dec December 12, 2023 Fostering bilateral trade and harmonized efforts in medicine regulation 07Dec December 7, 2023 ANVISA & ANMAT: Mutual Recognition Agreement for Medical Devices 04Dec December 4, 2023 Advancing Healthcare through Electronic Product Information 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
