Richard Denk knows Annex 1 to the EU GMP guidelines like the back of his hand: not only was he part of the industry commentary team for the second draft of the document, he also held training courses on the implementation of Annex 1 around the world following its publication. The training courses and workshops took place in Europe, the USA, Brazil, South Africa, Egypt, India, Singapore, Japan, Australia and New Zealand. Over a period of almost two and a half years, Richard Denk was able to gain many international impressions and was in dialogue with more than 15,000 people, sometimes intensively and lasting several days. In addition, Richard Denk was also invited by local and international authorities to conduct training courses on Annex 1.

We will talk to Mr Denk about his impressions and experiences from his world tour on the subject of Annex 1. We are also interested in his assessment of how the implementation of Annex 1 is progressing and what influence Annex 1 has on modern processes for the production of ATMPs and the topic of cell and gene therapy.