Featured Product In Regulatory Affairs
ICH Q10 Pharmaceutical Quality System — Unpacked and Refreshed
$159.00
If your goal is to create an effective quality system that won’t just check off boxes to satisfy the regulators, the advice and instruction found in ICH Q10 Pharmaceutical Quality System: Unpacked and Refreshed is the resource you need. It will ensure continuous improvement across the lifecycle of your products, and, ultimately, will align your quality activities with your business operations. Read More
Regulatory Affairs
CDER’s Priorities for 2022: What You Must Know About New Guidance and Program Plans – Webinar Recording/Transcript
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Communicating Directly with Consumers on Social Media: What You Must Know About FDA and FTC Ad and Promo Rules – Webinar Recording/Transcript
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Proving Comparability in Cell and Gene Therapy Development: Untangling FDA Requirements
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Organizing Data and Document Archives: Finding a Needle in a Haystack for FDA Inspections – Webinar Recording/Transcript
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Prepare Your Drug/Biologics Facility for the New FDA Inspection Model: Will It Be Remote, In-Person or Hybrid? – Webinar Recording/Transcript
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FDA’s Safety Reporting Requirements: Developing a Compliant Pharmacovigilance Plan
$129.00
Supply Chain Solutions: How the Pharmaceutical Industry Can End In-Bound Issue – Webinar Recording/Transcript
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Gene & Cell Therapy Regulation: Comparability and Other New Developments – Webinar Recording/Transcript
$287.00