Risk Management in Pharmaceuticals and BioTech

Why Should You Attend:

Risk Management is a topic which all Pharmaceutical and BioTech companies are required to understand to enable them to work toward mitigating those risks. These risks can be both product related, but also internal to the company with manufacturing risks, risks with Clinical Trials, or other risks related to drug development. This course will examine many of these risks and provide you with a better understanding of them and some tools to help you in mitigating or preventing them.

• Gain a better understanding of Regulatory Affairs and Quality Assurance Roles in Pharmaceutical Risk Management
• Better understand have the FDA has recently been considering Risk Management
• Understand the importance of FDA Communications with regard to Risk Management
• Understand how other departments are influenced by Risk Management and Risk Management decisions

Areas Covered in the Webinar:

• RiskMAPs and REMS
• Relation of Risk Management Programs to Labeling
• Physical Risk Management in Manufacturing
• Risk Management in Clinical Trials
• Major Risk Management Programs approved by FDA
• Risk Management in Ex-US Territories
• Risk Mitigation vs. Risk Minimization: Benefits of each
• Generics vs. Innovators

Who Will Benefit:

• Regulatory Affairs, Quality Assurance

Free Materials:

• Rule documents or guidance
• Slide Show
• Checklist