Contamination Control
The online event was organized by PharmaLex as a part of the 3rd edition of the international conference Biotech Atelier 2020
PharmaLex Bulgaria, a leader in the field of consulting services for the development, registration, and regulation of medicines and medical devices, organized the first online workshop on “Innovation in Medicine – ATMPs (advanced therapy medicinal products)”. The Member of the European Parliament Eva Maydell was a special guest at the company’s seminar. The event was part of the 3rd edition of Biotech Atelier 2020 – a two-day biotechnology conference organized by the Bulgarian Association for Personalized Medicine, and Prescriptia.
“We often underestimate the changes that will occur in the next years, and I believe that this is one of the main obstacles to fulfill the potential for digitalization across Europe. However, it is crucial to facilitate the dialogue between tech minds, the scientific minds and the policy minds, as both innovation and politics will continue to play a key role in our society and life – said Eva Maydell during her opening speech at the event. – I also think that it’s important for our success that both the business and the political leaders have a better understanding of the technology and are able to see the different opportunities for a positive change in society that technology and innovations can bring”, she added.
During the seminar, PharmaLex experts discussed the challenges, prospects, opportunities, and difficulties in developing, marketing authorization, reimbursement and patients’ access to ATMPs, which have emerged as a novel class of biological products offering huge potential for the treatment of diseases (cancer and rare diseases) and injuries, where limited or no alternative treatment options exist. ATMPs are a novel class of biological medicines that include somatic cells, tissue-engineered products, gene therapies, and a combination of a medical device that has embedded a cell or tissue components in it and have already demonstrated outstanding results in the treatment of patients.
ATMPs is a fast-growing area of novel and complex products that are still at its early stage of development. Despite the unique possibilities that these products offer, there are still many key challenges associated with their development, including regulatory, scientific, manufacturing, and commercialization ones. The participants in the event came to this final conclusion.
The international conference Biotech Atelier brings together leading Bulgarian and international experts in the field of Biotechnology, Healthcare, IT, Life Sciences, and Pharma, in order to promote innovation, creativity, entrepreneurial spirit of business and scientific professionals. In 2020, the conference was attended by over 800 experts from around the world, who join the mission to spark the next significant developments in biotechnologies and innovations.
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