Challenge / Obstacle: You are new to the organization and are developing the regulatory plans and strategies.
Tip: Realize the situation you have inherited. Before you can successfully reach your regulatory milestones, you must become familiar with the products, processes and people you will be working with. Understanding these dependencies is a prerequisite to making any progress.
Identify Key Stakeholders
A good place to start is to identify the key stakeholders and decision makers in each department. This exercise will show you how close what is on paper is aligned to what is done in practice. Finding out “who is who” in each department will come with an explanation of their activities… pay attention to the overall scheme and coordination that takes and the various approaches, tactics, and means each department uses to accomplish their tasks. You will need this understanding to be effective as a regulatory leader.
Once you’ve identified the key stakeholders and decision makers in each department, take the time to meet them and develop a good rapport. Understand and respect each department’s chain of authority and how they are connected to each other – your success as a regulatory leader will depend on your ability understand and utilize these structures that are in place.
Perform a Regulatory Due Diligence Audit
Knowledge is power. Before you embark on the adventures ahead, you must know what compliance gaps or performance obstacles may currently exist. An accurate assessment of the bottom line of your new company’s compliance status will need to include answers to the following questions:
Create Appropriate Regulatory Presence within the Organization
Where, when and how regulatory fits into each stage of the product development lifecycle will give you insight on the overall compliance standing of your company. When regulatory has early involvement in the processes that determine the safety and effectiveness of the product, compliance gaps are less likely. Regulatory presence throughout the organization also indicates greater potential for the capacity and effectiveness of your regulatory team and the regulatory plans and strategies you will be putting into place.
If you know anything about risk management, you know that the first choice method for risk mitigation is to design-out the risk (i.e. mitigate the risk by implementing design enhancements to the product). It’s the same concept for compliance management… the first choice method in reducing the probability of compliance issues for a company is to design-out any noncompliance and design-in compliance. This is accomplished by “designing” regulatory presence into each stage of the product development lifecycle. Best practices for the presence of regulatory affairs within pharmaceutical and medical device organizations must include all the functional areas that have the potential to create compliance issues.
The appropriate level of regulatory presence can be illustrated in the following example:
Where: Design control processes
When: At the beginning of the design planning stage. Preventing compliance issues always wins over correcting compliance issues.
Patricia Santos-Serrao is director of product strategy at MasterControl. She is a self-motivated, goal-oriented life sciences subject matter expert and industry solutions product manager with over two decades of experience in the pharmaceutical and biologics industry specializing in software solutions for quality management, regulatory affairs and clinical research business processes.
Patricia entered the life sciences industry working in regulatory and clinical operations at Schering-Plough and Boehringer Ingelheim Pharmaceutical and later transitioned into the solutions provider sector assisting small and large global life sciences organizations implementing various business process solutions during her time at CDC Solutions, Liquent, CSC and QUMAS. She has taken leadership roles in transitioning various organizations business processes around from paper to electronic systems for various business functions (including quality, manufacturing, regulatory and clinical).
She is a member of Regulatory Affairs Professional Society (RAPS) and has also earned her Regulatory Affairs Certification (RAC) from RAPS and the Regulatory Affairs Certification Board (RACB). She is also a member of the Drug Information Association (DIA) and a member of the TMF Reference Model Working Group (sponsored by DIA). She may be reached at email@example.com.
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