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Found 36 results for label/kegiatan.
Regulatory Affairs for FSP
PPD FSP regulatory affairs solutions help navigate regulatory approval and market access with comprehensive end-to-end regulatory services.
New European Union Regulation to Change How Clinical Trials are Conducted
Our experts explain what is changing and how to prepare for and navigate the transition to the EU Clinical Trials Regulation (EU CTR).
Real-World Data’s Role in Solving for Diversity in Clinical Research
Learn how using RWD and RWE to supplement trials provides understanding of safety and efficacy and effective off-label use.
Regulatory Insights: Regulatory Intelligence Informs Sound Clinical Trial Strategy
Discover how Regulatory Intelligence is used in the pharmaceutical product development process through helping to formulate clinical trial success.
The Complementary Roles of Wearables and Patient-Reported Outcomes in Patient-Focused Drug Development: Spotlight on Oncology Trials
Researchers incorporating wearables into their work should think of them as complementing — rather than replacing — insights from PROs.
Success Factors for eCTD Implementation in Mainland China and Taiwan
Our experts discuss advances for eCTD implementation in mainland China and Taiwan and detail three critical success factors for readiness.
Devices/Diagnostics: Emergency Use Authorizations During the COVID-19 Pandemic
Learn more about the increased uptake of Emergency Use Authorizations (EUA) for medical devices during the COVID-19 pandemic.
Key Considerations for Successfully Planning a Submission
Learn the importance of strategy formulation and regulatory engagement for planning a successful ISS/ISE submission.
Peri and Post-Approval
Biopharmaceutical companies are needing more and more evidence to prove value and effectiveness in post-approval settings, including how to communicate this evidence to payers, health authorities and other decision-makers.