Agenda
00:00 – Introduction
03:12 – Main points of the toxicological notification
19:29 – Questions to the audience
21:06 – Next steps in toxicological risk communication
30:52 – Conclusions
32:20 – Questions & answers
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Speakers
Dominiek Rossillion
As the Division Head of Quality Assurance at the QbD Group, based in Belgium, Dominiek brings extensive expertise to the table. He graduated as an Industrial Engineer in Chemistry (minor Biochemistry) and has over 17 years of experience in the life sciences sector. Throughout his career, he has held various roles in manufacturing (Quality, packaging, tech transfer, qualifications, …) and set up multiple successfully accredited QMS systems (ISO9001, 13485. GDP …). After gaining experience in sales, he now leads a team of 90 experts worldwide as the head of the QA Division.
Patricia Lugo Mariani
Meet Patricia, our Toxicology Coordinator at the QbD Group. She’s got quite the academic background. She graduated in Chemical engineering with a Master’s degree in Advanced Therapies and Biotechnological Innovation. She’s currently pursuing a PhD in Toxicology and Pharmacology at Complutense University of Madrid.
Patricia has a wealth of experience in microbiological research, including cell cultures, recombinant drugs, and physico-chemical lab work. She’s skilled at characterizing molecules, identifying impurities, and conducting CMC analysis. Additionally, she’s an expert at writing reports for regulatory agencies and has received GMP training. She’s also experienced in EMA and FDA audits.