Expert Forums
Overcoming key challenges in understanding and implementing guideline ICH Q14 for Analytical Procedure Development
Overcoming key challenges in understanding and implementing guideline ICH Q14 for Analytical Procedure DevelopmentJoin our experts, and by attending this forum, you will: Benefit from in-depth knowledge sharing and insightful discussions for a deeper understanding of...
Setting Biopharmaceutical Specifications: Navigating Regulatory Requirements in Accordance with ICH Q6B
Setting Biopharmaceutical Specifications: Navigating Regulatory Requirements in Accordance with ICH Q6BJoin our experts, and by attending this forum, you will: Gain in-depth knowledge and engage in insightful discussions to deepen your understanding of ICH Q6B. Learn...
Addressing Challenges in Analytical Validation: Understanding ICH Q2(R2) and Integration with ICH Q14
Addressing Challenges in Analytical Validation: Understanding ICH Q2(R2) and Integration with ICH Q14Join our experts, and by attending this forum, you will: Benefit from in-depth knowledge sharing and insightful discussions for a deeper understanding of ICH Q2(R2)...
Best Practices for Updating Analytical Procedures in Drug Development and Manufacturing
Best Practices for Updating Analytical Procedures in Drug Development and ManufacturingJoin our experts, and by attending this forum, you will: Learn the regulatory expectations for replacing or updating analytical procedures during drug development and manufacturing...
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Webinars
Overview of the ICH Q14 Guideline
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Key Challenges and Solutions in Implementing ICH Q14
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Overview of ICH Q6B guideline and current practice on specification settings
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ICH Q6B & challenges in setting patient-centric specifications
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Understanding the ICH Q2 Guideline
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Key Challenges and Solutions in Adapting to ICH Q2(R2)
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Articles
ICH Q14: Guideline Overview for Analytical Procedure Lifecycle Management
AdvertisementThe ICH Q14 guideline, formally part of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), represents a step forward in ensuring that analytical methods for pharmaceuticals are scientifically...
Quality Control in the (Bio)Pharmaceutical Industry: Safeguarding Medicines for Global Health
AdvertisementIn the pharmaceutical industry, the stakes for producing high-quality products are unparalleled. Medicines, whether traditional small molecules or advanced biologics, can save lives, prevent diseases, and improve quality of life. However, rigorous Quality...
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