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Optimising Interactions With Pharmaceutical and Medical Device Regulators
The Organisation for Professionals in Regulatory Affairs
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Professional Training
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From 675 GBP
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Multiple (2)
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Classroom, Self-Paced Online
Workshop leaders with industry and agency backgrounds will explain how to manage these critical interactions. This practical workshop also provides...
Out-Licensing: Best Practices in Presentations, Conferences, and Follow Up
PTI
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Professional Training
5.0
(4)
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From 430 GBP
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Online
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Self-Paced Online
In order to successfully secure an out-licensing partner it is crucial to attend partnering events such as BIO-Europe® and BIO-Europe...
Data Integrity: Beyond the Basics
NSF International, Health Sciences
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Professional Training
5.0
(2)
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Intermediate level
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From 145 GBP
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Online
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Self-Paced Online
This course (module 2) will build on the key messages of module 1 and go beyond the basics . It...
Lead Auditor EN ISO 13485:2016 and EU MDR 2017/745 - Regulation
ComplianceOnline
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Short University Courses
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Online
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Self-Paced Online
The new medical device regulation EU MDR 745/2017 in the European Union has a lot of new requirements. This new...
Examining the Q3D Guideline on Elemental Impurities - Online Academy
PTI
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Professional Training
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From 400 GBP
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Online
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Self-Paced Online
This four-module online course from PTI provides participants with an essential understanding of the ICH Q3D guideline on elemental impurities -...
FDA Presubmission Program – Requesting FDA Feedback
NSF International, Health Sciences
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Professional Training
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From 299 USD
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Online
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Self-Paced Online
The Q-Sub program is a voluntary mechanism to get FDA’s feedback on specific questions necessary to guide product development and/or...
Post Market Surveillance and Vigilance Requirements for Manufacturers (EU 2017/745)
NSF International, Health Sciences
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Professional Training
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From 299 USD
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Online
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Self-Paced Online
Post-market surveillance for manufacturers is covered in Articles 83-86. Articles 87-89 cover post-market vigilance requirements. This course reviews the requirements...
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