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Category: Regulatory & Safety

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Learn the importance of strategy formulation and regulatory engagement for planning a succesful ISS/ISE submission.
Learn the importance of strategy formulation and regulatory engagement for planning a succesful ISS/ISE submission.
Key Considerations for Successfully Planning a Submission
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PPD’s cross-functional EU CTR readiness team is keeping a close eye on the new EU CTR and its potential impacts, working to embrace this change.
PPD’s cross-functional EU CTR readiness team is keeping a close eye on the new EU CTR and its potential impacts, working to embrace this change.
Prepare Now for EU Clinical Trial Regulation Go-Live Date
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Learn more about the increased uptake of Emergency Use Authorizations (EUA) for medical devices during the COVID-19 pandemic
Learn more about the increased uptake of Emergency Use Authorizations (EUA) for medical devices during the COVID-19 pandemic
Devices/Diagnostics: Emergency Use Authorizations During the COVID-19 Pandemic
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Knowing when to outsource a REMS program versus developing one internally.
Knowing when to outsource a REMS program versus developing one internally.
REMS: To Outsource or Not to Outsource?
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Considerations for cell and gene therapy development have shifted based on recent updates published by the EMA and FDA.
Considerations for cell and gene therapy development have shifted based on recent updates published by the EMA and FDA.
New and Emerging Regulatory Guidance for Cell Therapy Product Development
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Cropped shot of young beautiful woman on third trimester of pregnancy. Close up of pregnant female with arms on her round belly.
Cropped shot of young beautiful woman on third trimester of pregnancy. Close up of pregnant female with arms on her round belly.
The Critical Need for Pregnancy Registry Studies and Robust Safety Monitoring in COVID-19 Vaccines
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PPD scientists predict the amounts of extractables and leachables (E&L) from container stoppers based on mathematical models.
PPD scientists predict the amounts of extractables and leachables (E&L) from container stoppers based on mathematical models.
Predicting Extractables & Leachables Amounts Using Mathematical Modeling
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Moderna Announces FDA Authorization of Moderna COVID-19 Vaccine in U.S.
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Time to Act is Now: Paediatrics Medicines Development in the UK
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