Pharmaceutical Regulatory Compliance

PHARMA EVOLUTION MOBILE
CPhI WORLD MOBILE

Featured Content

Single-Use Equipment ...

It's the users in biopharma who will benefit from ...

8 comments

No Nonsense Computer Systems ...

ISPE's GAMP is a useful guide, but may not be practical ...

7 comments

Product Volume & API Process ...

API manufacturing processes can be complex and ...

8 comments

FDA Crackdown on Compounders: Too ...

The FDA now admits that it could have done more to ...

12 comments

Changing Pharma’s Negative ...

Former Pfizer R&D chief John Lamattina proposes some ...

29 comments

ICH Q11 & Stealth QbD for Drug ...

Last May, ICH Q11 came on the scene without much hoopla, ...

6 comments

Illicit Designer Drugs: The ...

If the FDA were also given oversight of illegal drugs, ...

9 comments

So You Think You Know Lean?

Do you understand Toyota Production System concepts and ...

6 comments

Understanding Pharma Patents

Pharma's patent cliff is redefining the industry. Here, ...

5 comments

Question-Based Review, APIs & the ...

Question-Based Review could be a way to help ensure the ...

6 comments

Will Europe's Drive for Clinical ...

In the EU, the battle for formalizing clinical trial ...

12 comments

Pharma Evolution Blogs

Electronic Batch Records: Are Your Systems Ready for Inspection?

Jim Cahill, Head of Social Media, Emerson Process Management, 21/05/13 Comment now

Stringent inspection-readiness policies are common with pharmaceutical and biotech manufacturers. From a computerized system standpoint, the rules of Part 11 (Electronic Records; Electronic Signatures - Scope and Application) and ...

In-Silico Drug Development: A Must-Read Paper

Agnes Shanley, Editor-in-Chief, 20/05/13 Comment now

And now for the second article in the brief "technology of tomorrow" series...

Latest comment I felt like a contemporary of Jules Verne's must have felt when reading one of his novels when I read this paper. But why couldn't...

Can Simulation Take Drug Development Into the Future?

Agnes Shanley, Editor-in-Chief, 20/05/13 Comment now

At a time when some drug manufacturers still stumble on relatively simple concepts such as loading the correct amount of active ingredient in their formulations (something that may result in criminal charges for J&J executives in South ...

Latest comment Very complex issues here. The only way we could simulate any process is to understand, in excrutiating detail, EVERYTHING about the...

A Spoonful of Sugar

Adele Graham-King, Blogger, 17/05/13 Comment now

When I was young, we were given our polio vaccine on a sugar cube. We were given medicines full of sugar, we held our noses to take nasty suspensions, and we were regularly pinned down by our parents to ensure that we took the horrid ...

Latest comment Incredible though when the likes of the diabetes and asthma markets attract multi-million dollar investment to advance and improve...

Making New Drugs, Not Patients, the Guinea Pigs

Agnes Shanley, Editor-in-Chief, 16/05/13 Comment now

In traditional clinical medicine, patients are guinea pigs for new drugs. The risk of adverse -- or no -- effects is the price we pay for the potential of receiving treatment. But for those with terminal illnesses, even this risk is out ...

Latest comment I think that this could potentially provide interesting opportunities for terminally ill patients as so often they feel out of control...

PharmaEvolution Case Files 4

Agnes Shanley, Editor-in-Chief, 15/05/13 Comment now