Ausgabe 3/2024
Inhalt (8 Artikel)
Maximizing the Value of Real-World Data and Real-World Evidence to Accelerate Healthcare Transformation in China: Summary of External Advisory Committee Meetings
- Open Access
- Current Opinion
Feng Sun, Alexander Bedenkov, Bi-Cheng Liu, Jiefu Yang, Jin-fu Xu, Linong Ji, Min Zhou, Shaosen Zhang, Xinli Li, Yuanlin Song, Pingyan Chen, Carmen Moreno
Redefining the Role of Medical Affairs Professionals as Innovators and Leaders in Industry-Led Medical Education
- Current Opinion
Sajita Setia, Elliot Loo, Salil Prakash Shinde, Manmohan Singh, Chew Hooi Wong, Karan Thakkar
Conducting Drug Treatment Trials in Children: Opportunities and Challenges
- Review Article
Damir Erceg, Marina Jakirović, Luka Prgomet, Marina Madunić, Mirjana Turkalj
Authorized or Off-Label Use? A Structured Analysis of Summaries of Product Characteristics with Regard to Authorization in Pediatrics
- Open Access
- Original Research Article
Markus Herzig, Simone Eisenhofer, Meike Ruschkowski, Antje Neubert, Astrid Bertsche, Thilo Bertsche, Martina Patrizia Neininger
A Sponsor’s Perspective on the Contribution of Regulatory-Required Observational Post-Marketing Studies to Understanding Human Drug Product Benefit/Risk in Japan
- Open Access
- Original Research Article
Kevin D. Wolter, Asayuki Kamatani, Yumiko Suzuki, Takayuki Imaeda, Ramzi Dagher, Allan Safferman, Rod Junor
Survey of Data Package and Sample Size of Comparative Clinical Studies for Biosimilar Developments from PMDA Assessments
- Original Research Article
Ryosuke Kuribayashi, Aya Hariu, Ayuki Nakano, Yasuhiro Kishioka
Survey on the Situation of Medical Departments in the Pharmaceutical Industry in Spain
- Open Access
- Original Research Article
Isabel Sanchez-Magro, Susana Gomez-Lus, Javier Martínez-González, Jorge Andrés Muñoz-Robles, Yolanda Riesgo, Beatriz Perez, Carlos Hagen, Pablo Viguera
Trends in Adverse Event Reporting Before and After the Introduction of the Med Safety App in Nigeria
- Original Research Article
Uchenna Geraldine Elemuwa, Fraden Bitrus, Ibrahim Adekunle Oreagba, Adeline Ijeoma Osakwe, Abiola Sadikat Abiodun, Kenneth Onu, Asmau Abubakar, Angela E. Faniyi, Victoria Etuk, Daniel Yuah, Rametu Momodu, Christiana Mojisola Adeyeye
