Regulatory Roundup: EMA Reviews Drug Marketing Authorization Applications, And More. - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Regulatory Roundup: EMA Reviews Drug Marketing Authorization Applications, And More.

ePT--the Electronic Newsletter of Pharmaceutical Technology

Last week, the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) met to review and discuss drug marketing authorization applications. Several decisions were made (see full press release) including the committee’s recommendation to harmonize globally the prescribing information for Lipitor (atorvastatin).

Next week, in Bethesda, Maryland, ISPE and PDA will cohost a workshop on the implementation of pharmaceutical development, risk management, and quality systems as part of the ICH quality-trio workshop series. The workshop will feature members of the ICH Quality Implementation Working Group, including representatives from FDA and EMA, and include breakout sessions on design space, control strategy, quality system, and risk management. Industry is encouraged to attend.
 
 

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
Which of the following business challenge poses the greatest threat to your company?
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
Building a sustainable pipeline of products
24%
Attracting a skilled workforce
30%
Obtaining/maintaining adequate financing
15%
Regulatory compliance
30%
View Results
Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatcchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
Medicare Payment Data Raises Questions About Drug Costs
FDA Wants You!
A New Strategy to Tackle Antibiotic Resistance
Drug-Diagnostic Development Stymied by Payer Concerns
Obama Administration Halts Attack on Medicare Drug Plans
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
Click here