Redefining the Role of Medical Affairs Professionals as Innovators and Leaders in Industry-Led Medical Education Sajita SetiaElliot LooKaran Thakkar Current Opinion 15 April 2024
Maximizing the Value of Real-World Data and Real-World Evidence to Accelerate Healthcare Transformation in China: Summary of External Advisory Committee Meetings Feng SunAlexander BedenkovCarmen Moreno Current Opinion Open access 04 April 2024
A Sponsor’s Perspective on the Contribution of Regulatory-Required Observational Post-Marketing Studies to Understanding Human Drug Product Benefit/Risk in Japan Kevin D. WolterAsayuki KamataniRod Junor Original Research Article Open access 31 March 2024
Authorized or Off-Label Use? A Structured Analysis of Summaries of Product Characteristics with Regard to Authorization in Pediatrics Markus HerzigSimone EisenhoferMartina Patrizia Neininger Original Research Article Open access 31 March 2024
Survey on the Situation of Medical Departments in the Pharmaceutical Industry in Spain Isabel Sanchez-MagroSusana Gomez-LusPablo Viguera Original Research Article Open access 21 March 2024
Decentralisation in Clinical Trials and Patient Centricity: Benefits and Challenges Shubhadeep D. SinhaSreenivasa Chary SriramadasuSudeshna Roy Review Article 07 March 2024 Pages: 109 - 120
Advancing Rheumatology Care Through Machine Learning Thomas Hügle Leading Article Open access 29 February 2024 Pages: 87 - 96
Why Oncology Global Safety Teams Should Develop the Safety Section of the Study’s Target Product Profile (TPP) Michael E. Kieffer Current Opinion 27 February 2024 Pages: 97 - 108
Potential of Artificial Intelligence to Accelerate Drug Development for Rare Diseases Giulio NapolitanoCanan HasCarsten Ullrich Leading Article 05 February 2024 Pages: 79 - 86
Meaningful Within-Patient Change in Subjective Total Sleep Time in Patients with Insomnia Disorder: An Analysis of the Sleep Diary Questionnaire Using Data from Open-Label and Phase III Clinical Trials Andrea Phillips-BeyerAriane K. KawataBruno Flamion Original Research Article Open access 01 February 2024 Pages: 133 - 144
Physician Awareness of the Safe Use of Cyproterone Acetate in Europe: A Survey on the Effectiveness of Additional Risk Minimization Measures Carolyn SweeneyAlicia GilsenanFederica Pisa Original Research Article Open access 31 January 2024 Pages: 145 - 156
Emergency Approval Mechanisms for Human Vaccines in India Nidhi MehrotraPadmavati Manchikanti Review Article 24 January 2024 Pages: 121 - 132
Female Problems: Women’s Health Mustn’t be Ghettoized in the Uterus Peter J. Pitts Commentary 24 January 2024 Pages: 75 - 77
Rare Immune-Related Adverse Events (irAEs): Approach to Diagnosis and Management Anadil JavaidCatherine BennettLavinia Spain Review Article Open access 09 January 2024 Pages: 25 - 38
The Importance of Assessing Drug Exposure and Medication Adherence in Evaluating Investigational Medications: Ensuring Validity and Reliability of Clinical Trial Results Bernard VrijensAntoine PironetEric Tousset Current Opinion Open access 22 December 2023 Pages: 9 - 18
Eliciting Exploratory Patient Preference Data: A Case Study in a Rare Disease Kerrie-Anne HoAnna PierceCarol Mansfield Original Research Article Open access 21 December 2023 Pages: 55 - 62
“Regulatory Sandboxes” Could Solve the Regulatory Problems Encountered in Europe and Arising from Innovation in Biological Medicinal Products Mathieu Guerriaud Current Opinion 09 December 2023 Pages: 19 - 23
Evaluation of Physician Knowledge of Safety and Safe Use Information for Intravitreal Aflibercept Injection in Europe: A Second Survey of Physicians Following Dissemination of Updated Risk-Minimization Materials Laurie J. ZografosElizabeth AndrewsKiliana Suzart-Woischnik Original Research Article Open access 05 December 2023 Pages: 63 - 73
A Review of the Current FDA-Approved Antibody-Drug Conjugates: Landmark Clinical Trials and Indications Meghana KesireddySrikanth Reddy KothapalliSamia Asif Review Article 29 November 2023 Pages: 39 - 54
Strengthening the Pharmacovigilance System in Mexico: Implementation of VigiFlow and VigiLyze, as ICSR and Signal Detection Management Systems Gandi Rayón-RamírezSalvador Alvarado-LópezJorge Alcocer-Varela Leading Article 07 October 2023 Pages: 425 - 437
The Value and Deliverables of Medical Affairs: Affiliate Perspectives and Future Expectations Anupma Dhanda FarringtonAnne Grete FrøstrupPalle Dahl Leading Article Open access 03 October 2023 Pages: 417 - 424
Drug Repurposing for Spinal Cord Injury: Progress Towards Therapeutic Intervention for Primary Factors and Secondary Complications Lahanya GuhaHemant Kumar Review Article 12 September 2023 Pages: 463 - 490
Practical Considerations for the Implementation and Monitoring of Risk Minimisation Measures for High-Risk Teratogenic Medicines Marion MuellerJoseph PeakinDavid J. Lewis Review Article 18 August 2023 Pages: 439 - 449
Major Pharmaceutical Conferences and Courses: February 2024 to March 2024 Update 14 August 2023 Pages: 495 - 497
Correction to: The Risk Evaluation and Mitigation Strategy (REMS) Public Dashboard: Improving Transparency of Regulatory Activities Gita A. ToyserkaniJoann H. LeeEsther H. Zhou Correction 07 August 2023 Pages: 355 - 355
The Pharmacokinetics of Drugs Delivered to the Upper Nasal Space Stephen B. Shrewsbury Review Article Open access 03 August 2023 Pages: 451 - 461
Journey from an Enabler to a Strategic Leader: Integration of the Medical Affairs Function in ESG Initiatives and Values Daniel FurtnerGabor HutasRoland Meier Current Opinion Open access 18 July 2023 Pages: 405 - 416
Major Pharmaceutical Conferences and Courses: December 2023 to January 2024 Update 10 July 2023 Pages: 399 - 400
Association of Clinical Research Professionals (ACRP) 2023 Annual Conference Sue Pochon Meeting Report 08 July 2023 Pages: 395 - 397
Recognition of Coroners’ Concerns to Prevent Future Deaths from Medicines: A Systematic Review Robin E. FernerRichard BrittainJeffrey K. Aronson Systematic Review 08 July 2023 Pages: 357 - 363
The Risk Evaluation and Mitigation Strategy (REMS) Public Dashboard: Improving Transparency of Regulatory Activities Gita A. ToyserkaniJoann H. LeeEsther H. Zhou Leading Article 08 July 2023 Pages: 349 - 353
American Geriatrics Society Annual Scientific Meeting (AGS 2023) Caroline Herdson Meeting Report 06 July 2023 Pages: 491 - 493
A Survey of Industry Perceptions of Facilitated Regulatory Pathways in Drug Development in Australia Alina YoffeJohnson LiuOrin Chisholm Original Research Article Open access 27 June 2023 Pages: 385 - 394
Where is European Regulation 536/2014 Taking Us? Anthony W. Fox Current Opinion 24 June 2023 Pages: 343 - 347
Major Pharmaceutical Conferences and Courses: October to November 2023 Update 20 June 2023 Pages: 335 - 341
Perspectives on Adherence to Glaucoma Medical Therapy in Brazilian Patients Julia da Costa AndradeGuilherme Samomiya MottaNiro Kasahara Original Research Article 08 June 2023 Pages: 377 - 384
The Cost of Biotech Innovation: Exploring Research and Development Costs of Cell and Gene Therapies Marco T. SabatiniMark Chalmers Original Research Article 07 June 2023 Pages: 365 - 375
Meaningful Within-Patient Change on the Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ): Analysis of Phase III Clinical Trial Data of Daridorexant Andrea Phillips-BeyerAriane K. KawataDalma Seboek Kinter Original Research Article Open access 07 June 2023 Pages: 291 - 303
75th Annual Meeting of the American Academy of Neurology (AAN 2023) Sue Pochon Meeting Report 31 May 2023 Pages: 331 - 334
Interpersonal Values of Patients Participating in Phase II–III Clinical Trials: Implications for Clinical Trial Representativeness Rita GouveiaVitor Tedim CruzLuís Almeida Original Research Article 30 May 2023 Pages: 319 - 329
The Central Role of Ethics in Medical Affairs Practice Carl Naraynassamy Current Opinion 25 May 2023 Pages: 275 - 279
Current Status and Challenges of Pharmacovigilance of Traditional Medicines in French-Speaking West African (UEMOA) Countries Kampadilemba OuobaHélène LehmannRasmané Semdé Original Research Article 22 May 2023 Pages: 305 - 318
Tackling Counterfeit Drugs: The Challenges and Possibilities Ranjana PathakVaibhav GaurJaideep Gogtay Review Article 15 May 2023 Pages: 281 - 290
Embedding Patient-Centricity by Collaborating with Patients to Transform the Rare Disease Ecosystem Rohita SharmaSumaira AhmedLelainia Lloyd Current Opinion Open access 04 May 2023 Pages: 265 - 273
Black-Box Warnings of Antiseizure Medications: What is Inside the Box? Abdul WahabAttiya Iqbal Review Article 29 April 2023 Pages: 233 - 250
Clinical and Regulatory Challenges and Opportunities for Monoclonal Antibodies in Low- and Middle-Income Countries: Lessons from COVID-19 and Beyond Lisa GieberVincent Muturi-KioiAyesha Sitlani Current Opinion 28 April 2023 Pages: 203 - 214
A Science-Based Methodology Framework for the Assessment of Combination Safety Risks in Clinical Trials Andriani C. PateraJulie MaidmentKen Twomey Current Opinion Open access 26 April 2023 Pages: 183 - 202
