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Commercialisation Through Knowledge Exchange: GMP and GLP from the ACLEMETH Project

Commercialisation of innovation generated at research organisations or universities can happen in several ways. The ‘classical’ route involves licensing of IP rights to a company or starting a ‘spinoff’ company. But an alternative and very powerful and efficient approach for ‘valorising knowledge’ is by offering an expert service.

In the Republic of North Macedonia, a number of SMEs that want to introduce new production technologies in the field of pharmacy, especially in the production of herbal semi-finished products (extracts) and final pharmaceutical products, face the challenge of introducing a timely, continuous and step-by-step purpose-implemented system of Good Manufacturing Practice (GMP) as well as all other pharmacy-related practices e.g. GLP- Good Laboratory Practice and GPP – Good Pharmaceutical Practices. At present, there is no one who can advise them on how to do this. This is limiting their entry in to the market.

The ACLEMETH team from the Faculty of Medical Sciences, Goce Delčev University in Štip, are developing a custom e-learning tool on GMP. This will be offered to SMEs who need to understanding the issue of standards if they are to enter regulated market and to communicate with companies abroad including the supply chain. No such training currently exists in the Republic of North Macedonia and the overall approach of customised training packages using a company audit alongside standard training packages is new for the country and sector. Modernising this type of training offers an opportunity for the university team to enter in to wider regional and international markets and also to translate the approach for other sectors.

The business strategy of the team is to commercially exploit their know-how and experienced lecturers by offering a specific professional expert service, underpinned by a strong academic foundation. For this purpose, they plan to establish an independent Centre for Education and Training on Good Pharmaceutical Practices as a new University unit. With the support of the EU4TECH PoC project the ACLEMETH team aim to become a recognised knowledge service provider available for any specific need of the pharmaceutical industry.

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