Quintessence Enterprises Ltd organises the two-day training course "Toxicological evaluation in cleaning validation and risk assessment in the pharmaceutical industry" to help toxicological evaluation, cleaning validation and risk assessment stuff in the pharmaceutical industry develop the procedure for the determination of health based exposure limits for a residual active substance based on the method for establishing the so-called Permitted Daily Exposure (PDE).

The seminar takes place in Limassol, AYRA Training Centre, 12 Taki Sophocleous str., ...th and ...th December 2016 followed by the on-site visits.
Cross-contamination among production lines is an important issue in drug manufacturing, because it can put both patients and workers at risk of adverse health effects.

With the release of the latest version of Chapter 5; Production, the EU GMP Guideline suggests that pharmaceutical industries should develop a 'threshold value' for each of their products - either a Permitted Daily Exposure (PDE) or Threshold of Toxicological Concern (TTC) - which would be based on pharmacological and toxicological data from non-clinical and clinical studies

A toxicological evaluation should be the basis for the establishment of threshold values in relation to the products manufactured. Where the toxicological evaluation supports a threshold value, this should be used as an input parameter in risk assessment.

The two-day course is followed by a half-day on-site visit to each one of the participating pharmaceutical company to
• Determine a no-observed-adverse-effect level (NOAEL)
• Identify the hazards after reviewing contamination data
• Determine the adjustment factors to account for uncertainties

The PDE represents a substance-specific dose that is unlikely to cause an adverse effect if an individual is exposed at or below this dose every day for a lifetime. Determination of a PDE involves:
• Hazard identification by reviewing all relevant data
• Identification of “critical effects”
• Determination of the no-observed-adverse-effect level (NOAEL) of the findings that are considered to be critical effects, and
• Use of several adjustment factors to account for various uncertainties.

The seminar takes place in Limassol, AYRA Training Centre, 12 Taki Sophocleous str., ...th and ...th December 2016 followed by the on-site visits.

The announcement of the program is attached.

About the lectureres

Chrysa Daousani is a Senior Regulatory Strategy and Scientific Advice Consultant in drug development. Chrysa is an expert in Clinical/Pharmacokinetic and Non-clinical assessment and regulatory science. She represented Greece in the Committee for Medicinal Products for Human Use-CHMP at EMA (2012-2014) and also in the Co-ordination Group for Mutual Recognition and Decentralised procedure-CMDh (2008-2014). She worked as a Clinical/Pharmacokinetic and Non-Clinical Assessor at the Greek National Organisation for Medicines-EOF (2003-2014), where she coordinated and provided assessment for centralised, decentralised, mutual recognition and national procedures for medicinal products for human use, as well as for scientific and regulatory advice. From 2014, she runs her own Consulting company. She holds a BSc in Pharmacy from School of Pharmacy, National and Kapodistrian University of Athens, Greece, where she has also gained her MSc from Department of Pharmaceutical Chemistry. Currently she is also a PhD candidate in the Laboratory of Biopharmaceutics and Pharmacokinetics, School of Pharmacy, National and Kapodistrian University of Athens, Greece (scientific interests: biopharmaceutic drug classification, pharmacokinetics, modeling and simulation in drug development, drug ADME-T processes and PBPK modeling). She has received high-level scientific training from Academic and other Organisations as well as from the European Medicines Agency on Clinical and Non-Clinical/Toxicological Assessment of medicinal products.

Dr Michael Koupparis: Professor of Analytical Chemistry in the Departments of Chemistry and Pharmacy, University of Athens. BSc in Pharmacy (1973), PhD in Analytical Chemistry – Pharmaceutical Analysis (1978, University of Athens) and a post-doctoral position (1978-79, 1981, University of Illinois at Urbana-Champaign (USA). Member of the Laboratory of Analytical Chemistry, UOA, since 1974 and professor since 1994. He teaches wet-chemical analysis, instrumental analysis, advanced analytical chemistry, quality assurance, pharmaceutical analysis, quality control of drugs, statistics-chemometrics and research methodology to pharmacy and chemistry students and graduate students of several programs. Director of the academic laboratory of Analytical Chemistry and the Director of the Service Laboratory “Chemical Analysis – Quality Control” accredited with ISO 17025 and GMP. He is co-author of 3 books (Instrumental Analysis, Special Topics in Analytical Chemistry, Quantitative Calculations in Pharmaceutical Practice and Research) and the co-ordinator for the translation of the text-book “Pharmaceutical Analysis”. Advisor of 26 Doctoral Theses, 48 Master Theses and 20 Diploma Theses. His research interests include: automated methods of analysis, pharmaceutical analysis, bindings studies of drugs with macromolecules, HPLC, LC-MS, immunochemical analysis, quality control – quality assurance, bioequivalence studies. He published 175 research journal articles, 14 review articles and has 153 presentations in conferences. He is Lead Assessor of the Hellenic Accreditation System (ESYD) (2001-) for ISO 17025 and 15189. He gave a great number of seminars on Quality Assurance and Quality Control of Drugs. He is the President of the Pharmacopoeia Committee of the Greek National Organization (2000-) and member of the European Pharmacopoeia Committee (1997-). He is a specialist in quality assurance, quality control of drugs, validation of analytical methods and chemometrics. 
Achilleas Mitakos: Chemist MSc with experience on Industrial Pharmacy of Solids, Semi-solids and Liquids: Analytical Development, Quality Control and Quality Assurance.
Specialties: Project management, analytical, organizational, communication skills. Ability to prioritize and manage multiple tasks focusing on continuous improvement.