The pharmaceutical industry is rapidly evolving, adding new regulations as technology and medicines expand. Advancements affect assistive devices, drug marketing, labeling, and more, so healthcare transaction compliance plans need strict oversight to ensure the safety and trust of consumers. But such a complex process comes with challenges.
With a Master of Legal Studies in Compliance and Risk Management from Seattle University School of Law, you’ll be well prepared to assist companies with their regulatory needs, helping to prevent fraud and other abuses while ensuring that individuals receive the care they need from their providers. Whether you’re interested in pursuing a career advocating for patients’ privacy or training hospital staff on best practices, this program will provide the skills you need to be a leader in pharmaceutical industry compliance.
The Importance of Pharmaceutical Compliance Regulations
As with any product used by consumers, the safety and efficacy of medication is a crucial component in the quality control process used by manufacturers. However, due to dynamic regulations within the pharmaceutical industry, many companies find themselves inadvertently violating manufacturers or labeling laws. Working with complicated ingredients, navigating supply chain disruptions, and ensuring the proper maintenance of data are just a few of the challenges these companies face. Ultimately, companies may face a blow to their reputation, financial losses, fines, and even criminal charges, while consumers face potential health hazards and a loss of trust in their chosen healthcare organization or brand. With the right compliance plans in place, these issues can be sussed out and eliminated before they become major concerns for everyone involved.
Why Post-Manufacturing Compliance Is Just As Crucial
In the pharmaceutical industry, creating the product is only part of the job. Once medications are ready to distribute, they must be labeled and packaged correctly to avoid confusion on the part of the consumer, as well as to prevent false claims from influencing their purchase. Labels may include important details such as:
- Dosage amounts
- Active ingredients
- Lot numbers, expiration dates, and National Drug Code numbers
- Drug interactions
- Storage guidelines
- Symbols
- Barcodes
One important aspect of ensuring compliance within the pharmaceutical industry is preventing companies from exaggerating the role of a certain ingredient, which means that labeling must be clear about the efficacy of a given drug while using the correct terminology. Understanding the laws surrounding these regulations will allow you to work with a variety of organizations and individuals to promote safety and regulatory adherence across the board.
Work With Patients Who Need An Advocate
Healthcare compliance laws extend to many different areas, from doctor’s offices to senior care facilities. Compliance officers with legal knowledge are invaluable in these settings, as they can advocate for patients and help organizations avoid HIPAA violation penalties at the same time. Due to numerous advances in technology in recent years, patient information is more at risk than ever, so it’s imperative that all healthcare workers are up-to-date on the latest best practices for cybersecurity. With an MLS in Compliance and Risk Management, you can affect policies, create training tools, and oversee the privacy of patients whose sensitive data is used, transferred, and stored across various platforms.
Prepare For A Successful Future
One of the many qualities compliance managers must learn is the ability to pivot in the face of unexpected challenges. With new privacy issues and tech being unveiled every day, it’s crucial that you’re able to keep a level head under pressure. You’ll also need to look to the future a bit by preparing for unforeseen problems; this will necessitate keeping up with the latest news in your chosen field and building a strong network of peers who can help you see what the industry is facing.
Seattle University School of Law offers three courses that focus on healthcare compliance, providing a rich curriculum taught by experienced instructors: Healthcare Law, Healthcare Industry Compliance, and Healthcare Transactions Compliance. During your time in the MLS program, you’ll gain the skills you need to build a career that works for you, all while learning how to make a meaningful impact on the lives of others. Take a look at the course requirements today to learn more.
