In November 2012, the European Union (EU) mandated use of the ICH-recommended Periodic Benefit Risk Evaluation Report (PBRER) in a new PSUR – responding to the increasing need to understand and manage the post-authorization safety benefit-risk profile of a drug. Adopted in many regions, the main objectives of the PBRER are to:
- Present a comprehensive and critical analysis of new or emerging information on the risks of a drug;
- Highlight any new evidence of the potential benefits of a drug; and
- Allow for the determination of a drug’s holistic benefit-risk profile.
Now that both regulators and the industry alike have had almost two years of experience evolving the expectations of how PBRERs should be written and assessed, biopharmaceutical companies must create streamlined processes that will allow them to develop consistent standards for meaningful benefit-risk assessments.
During this webinar our presenters will provide five best practices you can use to:
1. Develop useful SOPs, work instructions, checklists and templates that will streamline processes and optimize methods of data collection and analysis for your PBRERs.
2. Overcome some of the more challenging sections of PBRER preparation.
3. Respond to PBRER feedback and requests from Pharmacovigilance Risk Assessment Committee (PRAC) and Regulatory Authority.
4. Leverage the modular approach, which encompasses common sections within Development Safety Update Report (DSUR) and Risk Management Plan (RMP).
5. Effectively manage multi-region submission waivers and timelines.
Dominique Coleman, Director, Safety Aggregate Reporting and Analytics (SARA), Quintiles
What she does: In her capacity as Director of SARA at Quintiles, Dominique is responsible for the writing and review of aggregate reports, including PBRERs, required by regulatory authorities. She is also responsible for writing and reviewing documents required to manage the benefit-risk of both investigational and marketed products in a company’s portfolio. Dominique has 16 years of experience in the field of pharmacovigilance.
Education: Dominique has a Masters in Pharmacovigilance, an honours degree in Biochemistry.
Carrie Messina, Safety Aggregate Reporting Manager for the SARA group, Quintiles
What she does: Carrie’s nursing career began as a Level 1 Trauma Registered Nurse (RN) in Emergency Departments until 2002, when she switched to Pharmacovigilance as a Senior Medical Analyst / Pregnancy Registry Coordinator for Abbott Laboratories. Subsequently, Carrie advanced her career by becoming a Senior Medical Writer III of safety aggregate reporting at Baxter Laboratories and Abbott Laboratories, followed by Team Lead responsibilities as a Pharmacovigilance Specialist at Healthcare ConneXions (formerly known as SentRx).
Special Interests: Carrie is married with twin 7-year old boys and has two dogs. Carrie enjoys friends, family, swimming, bicycling, walking, exercise, traveling and watching her children play and learn.
Education: Carrie has a Bachelor’s Degree in Nursing from Florida International University and a Bachelor’s degree in Biology (major) and Chemistry (minor) from Northern Illinois University.
Who Should Attend?
- Pharmacovigilance officers
- Drug safety officials
- Medical directors
- Compliance officers
- Executive management
- General/corporate counsel
- Risk management specialists
- Academic researchers
Quintiles (NYSE: Q), a Fortune 500 company, is the world’s largest provider of bioPharmaceutical development and commercial outsourcing services. With a network of more than 29,000 employees conducting business in approximately 100 countries, we helped develop or commercialize all of 2013’s top-100 best-selling drugs on the market. Quintiles applies the breadth and depth of our service offerings along with extensive therapeutic, scientific and analytics expertise to help our customers navigate an increasingly complex healthcare environment as they seek to improve efficiency and effectiveness in the delivery of better healthcare outcomes. To learn more about Quintiles, please visit www.quintiles.com.