Module 6

04/10/2024

Issue Management & Regulatory Affairs

Methods for Identifying Issues

Strategies for Effective Issues Management

Regular audits and inspections

Proactive monitoring and early detection Strong internal communication channels

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Monitoring regulatory updates

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Feedback from stakeholders

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Internal reporting systems

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• Continuous training and education

The Organisation for Professionals in Regulatory Affairs

Issues Management or Managed by Issues?

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Recent Example Issue Management COVID-19

The AstraZeneca COVID-19 vaccine faced several issues during its rollout, which required careful management by health authorities:

The Comirnaty (Pfizer/BioNTech) COVID-19 vaccine did face some issues, but they were different from those seen with the AZ vaccine:

1. Blood Clot Concerns : One of the most significant issues was the rare occurrence of blood clots, specifically cerebral venous sinus thrombosis (CVST), in some recipients. This led to temporary suspensions and reviews by various health agencies, including the EMA and the MHRA. . 2. Age Restrictions : Initially, there were disputes over the vaccine’s efficacy in older adults, particularly those over 65. Some European countries initially restricted its use in this age group until more data became available. challenges in meeting its supply commitments to the European Union, leading to tensions and legal disputes over vaccine deliveries. 4. Public Confidence : The mixed messages and changing guidelines around the vaccine’s safety and efficacy impacted public confidence. Authorities had to work hard to reassure the public and provide clear, consistent information. 3. Supply Chain Challenges : AstraZeneca faced significant

1. Myocarditis and Pericarditis : There were reports of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining around the heart) following vaccination, particularly in younger males. Regulatory agencies like the EMA and MHRA added warnings to the product information and continued to monitor these rare side effects. 2. Allergic Reactions : Early in the rollout, there were concerns about severe allergic reactions (anaphylaxis) in some individuals. This led to updated guidance on screening for allergies and managing potential reactions at vaccination sites. 3. Storage and Handling : The Comirnaty vaccine required ultra-cold storage, which posed logistical challenges for distribution and administration, especially in less equipped regions. 4. Booster Doses : As new variants of the virus emerged, there were discussions and studies about the need for booster doses to maintain immunity. This required ongoing communication and updates to vaccination strategies.

The Organisation for Professionals in Regulatory Affairs

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