|
|
|
|
|
|
|
 |
28 |
 |
|
|
- Utilizing effective systems to ensure
continuous improvement of existing
processes and sustained compliance
with government and industry
standards.
- Maintaining professional and effective
relations with government regulatory
agencies and consistently meeting
our commitments to those agencies.
- Tracking and properly reporting
adverse drug events and product
quality complaints to the appropriate
regulatory authority in accordance
with applicable law and regulations.
- Following all procedures regarding
the reporting, investigation and
tracking of adverse drug events and
product quality complaints so that
this information can be properly
reported to the appropriate regulatory
authority in accordance with
applicable law and regulation.
Animal Welfare
Schering-Plough is committed to the
proper use of animals for research
purposes.
This means:
- Always providing humane care and
treatment to research animals.
- Replacing animal studies with
alternative methods wherever
reasonably possible.
|
|
|
|
|
Q. The law of my country requires us to report an adverse event caused by a Company product regardless of where it occurred. But, the standard industry practice in the country is only to report an adverse event when it happens within the country. The regulators won’t accept reports about adverse events that occur outside their jurisdiction. What should I do?
A. Schering-Plough reports all adverse events and follows the law of the country, no matter what the industry practice is. You should contact Global Pharmacovigilance so that the event can be formally reported in every jurisdiction where it is required. Animal Health-related adverse events should be reported to Animal Health Regulatory Affairs in your country.
|
|
