FDAnews Announces — ICH Stability Requirements: Overcoming the Challenges Webinar, July 20, 2017

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Drugmakers all too often overlook a critical step in the new-drug-approval process. Here’s what it is, and how to correct it.

ICH Stability Requirements:
Overcoming the Challenges
**An FDAnews Webinar**
July 20, 2017 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/ich    

When it comes to new drug approvals (NDA), the smallest thing can trip drugmakers up.

For example ICH stability requirements. Drugmakers may view this step in the process as a tedious irritation and brush it off — only to face an FDA deficiency letter, or worse.

But stability is a critical quality attribute, with complex and confusing rules that vary from country to country and regulator to regulator. Failure to comply can result in drug approval delays, shortened shelf lives and other costly misfortunes that cash-strapped drugmakers can ill afford.

It’s time to master ICH stability requirements.

Mark the calendar for Thursday, July 20, when FDAnews presents an all-new webinar on mastering this oft-neglected step in the approval process.

Ph.D. biochemist Dr. Wayland Rushing, Senior Scientific Advisor, ABC Laboratories, is the guide. In an information-packed hour and a half, he’ll spell out what the ICH stability requirements (ICH Q1A(R2)-Q1F) say and what they mean and show how to tailor compliance to drugmakers specific products. Attendees will learn:

  •     The requirements for ICH stability studies
  •     The requirements for analytical methods
  •     How to interpret data generated by the stability programs
  •     How to design the right stability programs for particular drugs
  •     And much more!

Drug-approval delays can cost millions of dollars. Don’t take that risk, not when the knowledge needed is close at hand. Register today.

Meet the Presenter:
Wayland Rushing Ph.D., Senior Scientific Advisor, ABC Laboratories, is a technical expert in chemistry, manufacturing and controls (CMC) program design, analytical development and regulatory submissions.

Who Will Benefit:

  •     Drug Development Professionals
  •     CMC Analytical Personnel
  •     Stability Managers
  •     Manufacturing Executives
  •     QA/QC
  •     Regulatory Affairs
  •     Program Management

Webinar Details:
ICH Stability Requirements:
Overcoming the Challenges
**An FDAnews Webinar**
July 20, 2017 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/ich    

Tuition:
$287 per site

Easy Ways to Register:
Online:     http://www.fdanews.com/ich                                                                                        
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
FDANEWS
+1 (703) 538-7665
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