CEC: Preclinical Drug Evaluation: Pharmacology, Toxicology, and Safety Thresholds (PDE, TTC, MACO..)

Pr. Abderrazek Hedhili, Professor of Toxicology, Faculty of Pharmacy of Monastir (FPHM), Cabinet Advisor to the Ministry of Health, Director of the Toxicology-Environment Research Laboratory (LR12SP07), Member of the French National Academy of Pharmacy, WHO ICSC Expert & Vice President of the AFCB
Pr. Wahiba Douki, Pr. Dorra Amira, Pr. Mohamed Ali Soussi, Pr. Ag. Mohammed Amine El Kaibi, Pr. Ag. Nadia Chaouali, Pr. Ag. Asma Ben Abdelaziz, Dr. Soumaya Hlaili Miled, Dr. Houda Rahmani, Dr. Aida Chekir, Dr Nabil Said. The Faculty of Pharmacy of Monastir announces the launch of a new Certificate of Complementary Studies (CEC) entitled: “Preclinical Drug Evaluation: Pharmacology, Toxicology, and Safety Thresholds (PDE, TTC, MACO..).”

This program is designed for pharmacists, physicians, residents, and industrial professionals who wish to master the critical analysis of pharmacological and toxicological data required for drug development and Marketing Authorization (MA/AMM) dossiers.
The training focuses on the scientific justification, calculation, and defense of safety thresholds such as Permitted Daily Exposure (PDE), Threshold of Toxicological Concern (TTC), and Maximum Allowable Carryover (MACO).
This certificate offers a unique opportunity to harmonize professional practices with international regulatory requirements (ICH, EMA, FDA, WHO) and to integrate toxicological safety thresholds into industrial activities, in particular the validation of cleaning and the management of cross-contamination risks.

• Pharmacists and Physicians
• Pharmacy Residents
• Engineers and Scientific Managers
• Regulatory Affairs Managers and Inspectors
• Research Professor

   Upon completion of this CEC, participants will be able to:

• Master preclinical integration: Understand the essential link between preclinical pharmacological and toxicological studies and the global drug development process.
• Identify experimental models: Evaluate various experimental models
• Apply calculation methodologies: Correctly apply internationally recognized methodologies to calculate PDE, TTC, and MACO based on critical data like NOAEL, LOAEL, or BMD.
• Manage industrial risks: Integrate safety thresholds into industrial quality control, cleaning validation, and risk management strategies for complex substances (CMR substances and cytotoxic compounds).
• Defend regulatory dossiers: Develop the skills to write rigorous regulatory reports and defend safety dossiers during audits and inspections.

The teaching program of this certificate is organized around five complementary modules :

• Module 1: Regulatory toxicology and preclinical trials for marketing authorization
• Module 2: Regulatory frameworks
• Module 3: PDE, TTC, MACO calculation methodology
• Module 4: Industrial applications
• Module 5: Audits, inspections, and file defense

Each module comprises several teaching units (UE), as outlined in the table below, indicating the corresponding number of teaching hours.
The detailed timetable and exact session dates will be communicated to enrolled participants at the beginning of the CEC.
Teaching will be conducted by nationally and internationally recognized experts in the fields of pharmacology, toxicology, and pharmaceutical regulatory affairs.
 

Module	Teaching Units (UE) & Key Contents	Hours
Module 1: Regulatory toxicology and preclinical trials for marketing authorization	UE1: Development of the drug and overall framework for Marketing Authorisation UE2: Preclinical pharmacological exploration UE3: Experimental models in preclinical studies UE4: Regulatory toxicology: pre-toxicological tests required for the marketing authorization UE5: Non-clinical transition to clinical trials	50 h
Module 2: Regulatory frameworks	UE1: International regulatory frameworks (ICH, OECD, WHO, EMA, FDA) UE2: National regulatory frameworks: Tunisian national framework and Good Laboratory Practices (GLP)	10 h
Module 3: PDE, TTC, MACO calculation methodology	UE1: Critical Data Choice UE2: Application of uncertainty factors UE3: PDE, TTC, MACO depending on the exposure routes UE4: Special cases: CMR and cytotoxic substances UE5: Practical exercises	15 h
Module 4: Industrial Applications	UE1: Situation in Tunisia and round table UE2: Visits to Tunisian Industries	20 h
Module 5: Audits, inspections, and file defense	UE1: Expectations of the authorities UE2: Non-conformities related to toxicological studies and the PDE UE3: Drafting regulatory reports UE4: Audit simulations	15 h
TOTAL		110 h

 
 

• Final Written Examination (60%): A comprehensive exam covering all modules, scheduled for April 2027.
• End-of-CEC Project & Defense (40%): This assessment consists of analyzing a preclinical dataset, identifying key data, and conducting a fully justified calculation of the Permitted Daily Exposure (PDE), which must be submitted as a dissertation and presented during an oral defense.
• Success Criteria: A minimum overall grade of 10/20 is required for the issuance of the certificate.