A) WHO SHOULD ATTEND THE WORKSHOP:

All professionals in the pharmaceutical industry from the departments of regulation, medical affairs, pharmacovigilance, medical information and quality assurance who wish to deepen their knowledge of the field of patient safety with new national and international challenges and requirements.

B) OBJECTIVES FOR PARTICIPANTS:

• Acquire regulatory bases and new international guidelines (Food and Drug Administration, European Medicine Agency, Health Canada, ICH and Saudi Food and Drug Authority…)
• Master the tools for implementing a compliant (100% compliance) and efficient patient safety system within a pharmaceutical company. (Patient safety is a permanent goal to develop efficient health products with maximum benefit and minimal risk).
• Develop in-depth knowledge of the roles and responsibilities of the various departments on patient safety within the pharmaceutical industry. (Regulatory, Medical Information, Pharmacovigilance, Quality Assurance)
• Prepare and assist pharmaceutical companies with internal audits and inspections of health agencies / authorities.

C) CONTENT:

• State of the new Algerian and international regulations (FDA, EMA, Health Canada HC, SFDA…)
• Case management for adverse reactions and product quality complaints
• Investigation related to product quality
• Management of complaints related to product quality
• Develop in-depth knowledge of the roles and responsibilities of the various departments on patient safety within the pharmaceutical industry.
• Patient record / collection of information
• Workshop with Quiz: example of the Canadian model and practical cases on an online security basis

D) HOURLY VOLUME:

• General notions
• Regulation
• Pharmacoepidemiology
• Data managment
• A 3-hour module with a coffee break
• A 1-hour workshop with questions and answers

E) THE 50,000 D.A PACKAGE INCLUDES:

• Coffee break
• Educational support
• Training certificate
• Free 20-minute personal consultation and networking session on Pharma business opportunities in North America.