ECA Certified
Biotech Manager

ECA Certified Biotech Manager

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.

Courses and Conferences acknowledged

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".

  • Protein Analytics
  • GMP for Advanced Therapy Medicinal Products (ATMP
  • Bioassays and Bioanalytics
  • Stability Testing for Biological/Biotechnological Drug Substances and Drug Products
  • Pharmaceutical Biotechnology for Non-Biotechnologists
  • GMP for Vaccine Manufacturers - Current regulatory requirements and practical implementation

Your Questions

For questions relative to the ECA Certified Biotech Manager, please contact heimes@gmp-compliance.org.

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