|
|
An
Overview of EMEA and Centralised Procedure
Dr. Ulrich Granzer
Granzer Regulatory Consulting and Services
Recording
- US$249
|
 |
European
legislation governing pharmaceutical regulations has undergone
a major revision in recent years. It began with an initiative
of the EU Commission in 1999, and culminated in the implementation
of a new regulation concerning the structure and the name of
the EMEA, the European Medicines Agency.
These
sweeping changes also affected the centralised procedure, with
major revisions regarding fast track, conditional approval and
approval under exceptional circumstances. Furthermore,
the basic EU pharma legislation, Directive 2001/83, has been
changed to adapt to the needs of the enlarged European Union
including 25 full members plus Iceland, Norway, and Liechtenstein.
In
this audio conference, Dr. Granzer will discuss the changes
impacting pharmaceuticals in the EU, and how best to navigate
the maze in getting your products to market.
This
audio conference will cover:
- How the
EMEA works
- How the
different gremia work
- Latest
update on the centralised procedure
- What
is conditional approval good for?
- When
is the centralised procedure mandatory?
- When
is there an option to use the registration system?
About
the speaker:
Ulrich
Granzer, PhD is owner of Granzer Regulatory Consulting and Services
(www.granzer.biz), providing consulting services to pharma and
biotech companies on all aspects of drug development and regulatory
affairs. Dr. Granzer has extensive industry experience, having
held senior positions at Glaxo, BASF Pharma - Knoll, and Bayer.
He has been involved in the development and registration of
products targeting HIV, asthma, pain, chemotherapy induced emesis,
several biological compounds directed against the sequelae of
stroke, septic shock, and rheumatoid arthritis.
He
also played a significant role in development of the first fully
human anti TNF antibody, now marketed as Humira. Dr. Granzer
has worked on more than 100 NME's and MNE - submissions in several
major indications like HIV, rheumatoid arthritis, asthma, pain,
cancer, stroke, tissue regeneration with small molecules and
biologicals.
Who should
attend?
- Senior
Management
- Chief
Medical Officers
- Chief
Scientific Officers
- Regulatory
Affairs Managers
- Business
Development Managers
- Legal
Counsel
Purchase
Options:
|
