X
Cookies help us improve your website experience.
By using our website, you agree to our use of cookies.


最新的帖子

一月 17, 2020

The Latest on Regulations: ICH Guideline to Manage Change throughout the Commercial Lifecycle of Drugs and Combination Products – Part 2

Part 1 of this two part blog series, gave a high-level overview of the new ICH guideline <em>Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management</em>.&nbsp; In part 2 of this blog series, some of the key takeaways will be discussed in more detail.&nbsp; <em>Q12</em> is intended to help companies demonstrate increased product and process knowledge, and understand which post-approval changes will require a regulatory submission, as well as the level of reporting for each category.
Fran DeGrazio

Fran DeGrazio

VP Scientific Affairs and Technical Services

以前的博客
Regulatory Check List

七月 01, 2019

European Medicines Agency's (EMA) Strategy on Engaging with Regulatory Science

Bettine Boltres

Bettine Boltres, Ph.D.

Principal, Scientific Affairs, Packaging & Delivery Systems

CPhI China Tradeshow

六月 20, 2019

West Helps Simplify the Journey™ in China

Jessie Zhang

Jessie Zhang

Manager, Global Communications, AP

Particle Analysis

六月 11, 2019

Particulate Challenges

Fran DeGrazio

Fran DeGrazio

V.P. Technical Customer Service & Scientific Affairs

A nurse extracting a medication from a vial into a syringe

六月 04, 2019

Are You Ready? Compliance with New USP Chapters <381>, <382>, <1381> and <1382>

Daniel Bantz

Daniel Bantz

Technical Manager, Packaging & Performance, Laboratory

Introducing Integrated Solutions

五月 02, 2019

FDA Guidance Affecting cGMP Compounding Pharmacies (503Bs)

Amy Kim

Amy Kim

Sr. Specialist, Scientific Communications, SA & TS

SmartDose Platform

四月 26, 2019

Overcoming Challenges Associated with Biologic Drug Formulation and Development

Victoria Morgan

Victoria Morgan

Director, Segment Marketing, Global Biologics

What's New In the West Knowledge Center

四月 16, 2019

What’s New in the Knowledge Center?

Tara Haarlander

Tara Haarlander

Sr. Specialist, Scientific Communications

Load more