Pharmaceutical Technology E-Alert:
Having trouble viewing this e-mail? Click here.
  Pharmaceutical Technology Europe E-Alert
 
29 June 2012

IN THIS ISSUE
Roche Investigation
FDA Warning Letters
Pharmacovigilance Guidelines
Teva Lawsuit



EMA Investigates Roche for Deficiencies in Safety Reporting
The European Medicines Agency has launched an investigation into Roche after an inspection found that thousands of potential safety reports, including 15161 deaths, connected to Roche medicines had not been evaluated to determine whether they should be reported to regulators as adverse drug reactions. More...
 
FDA Updates List of Warning Letters
FDA has updated its website to include the latest Warning Letters issued to pharmaceutical companies by the Office of Prescription Drug Promotion and the Centre for Drug Evaluation and Research. Improper training and a lack of written procedures were among some of the citation trends. More...
 
EMA Finalises Pharmacovigilance Guidelines
The European Medicines Agency has published its first set of finalised guidelines concerning good pharmacovigilance practices (GVP). The guidelines are a key deliverable of Europe’s pharmacovigilance legislation, which will come into effect on Monday 2 July. More...
 
Teva Wins Patent-infringement Lawsuit Protecting Copaxone
A US Court has ruled in favour of Teva Pharmaceuticals in the company’s patent-infringement lawsuit against Momenta Pharmaceuticals/Sandoz and Mylan Laboratories/Natco Pharmaceuticals regarding Teva’s relapsing-remitting multiple sclerosis product, Copaxone. More...
 
All atweet!
Keep up to date with the latest news, gossip and rumours hitting the web about the pharmaceutical industry by following us on Twitter. More...
Key Topics:

Latest blog posts
Deficiencies in Roche Safety Reporting
Seminar Addresses Developments and Challenges in Hot Melt Extrusion
Day Three at ACHEMA
More blog posts

Latest articles
Peptides Gain Traction in Drug Development
Freeze-Drying Process Optimisation for a Small Molecule
Advanced Tablet-Coating Technologies Aid Manufacturing Efficiency
More articles

Upcoming events
Social Media in the Pharmaceutical Industry (9–10 July | UK)
REACH and CLP USA (21–23 August | USA)
CPhI South America (21–23 August | Brazil)
More events

Recruitment Profile

Council of Europe
Scientific Programme Officer - OMCL Quality Assurance Programme (Grade A1/A2)
Duty station: Strasbourg (France)
Ref No: e146/2012
Read more


Products/Service Profiles
LB Bohle

Granulation in a new dimension
L.B. Bohle developed an elegant solution for a completely smooth running process in traditional granulation equipment.
The new Compact Unit features a high-shear mixer and fluid bed dryer side by side, complete with sieving step in between.
Read more

 
Marchesini

Marchesini Group is an international leading supplier of automatic packaging machines and complete lines for the pharmaceutical and cosmetic industries.
Read more


Recruitment Profile

Council of Europe
Scientific Programme Officer - OMCL Quality Assurance Programme (Grade A1/A2)
Duty station: Strasbourg (France)
Ref No: e146/2012
Read more


Company Profile

TSI Incorporated
TSI Incorporated Introduces Innovative Solution for Real-time Viable Particle Detection
TSI introduces the BioTrak™ Real-Time Viable Particle Counter for monitoring pharmaceutical cleanroom facilities.
Read More


Event Profile

Pharma Integrates 2012
Nov 28-29 2012
London, UK
Where do you see partnerships strategically?
This is the central question that Pharma Integrates 2012 (PI2012) will tackle. PI2012 is the exclusive retreat for the bio/pharmaceutical procurement and outsourcing elite.
Read more

 
Survey
 
Does your company have a system in place to alert regulatory authorities when and if you foresee a shortage of your material or drug product?
 
Yes 36%
 
 
No 49%
     
 
No, but we are developing such a programme 15%

This week we would like to know...

Are you in favour of the US Supreme Court overturning the Affordable Care Act and its associated biosimilars pathway?

Click here to vote

Contact Us
Click here to contact editorial.

Click here to contact sales.