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 From a historical view,
Biopharmaceuticals are no new business. Antibiotics and vaccines have been well known for more than 60 years. But with the marketing authorisation of the first pharmaceutical
product, produced by gene technology in the 80s, a new era of biopharmaceutical and biotechnological development and manufacturing started.
In 2007, 20% of all new released pharmaceuticals were Biopharmaceuticals. In defiance of all throw-backs in the last years, a progression of new approvals of biopharmaceuticals
is expected. Furthermore, after the end of the protection of patents, biotechnical generics will be added.
Due to the specifics in biotechnology, fulfilling the regulatory requirements in the manufacture and quality assurance of biotech products is a tremendous challenge, and industry
as well as authorities are constantly treated with new and expected changes in the regulatory guidelines.
ECA stays abreast of these changes. The new Certification Programme "ECA Certified Biotech Manager" provides you with the opportunity to acquire the necessary knowledge and qualification
to fulfil the current requirements in GMP for pharmaceutical Biotechnology.
For questions relative to the ECA Certified Biotech Manager, please contact
heimes@gmp-compliance.org.
To receive the certificate, the applicant must attend three out of the
following courses / conferences. After attending the third course, the
applicant obtains the certificate "ECA Certified Biotech Manager".
- Biotechnology for Non-Biotechnologists
- Bio Production Forum
- Protein Analytical Technologies
- GMP for Vaccine Manufacturers
- cGMP for Biopharmaceuticals
- Development of Biopharmaceuticals
To get to the calendar with all courses and conferences currently offered
for this programme - including a link to the contents and a booking form -
please go here.
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