Episode 02 Navigating the Safety Seas of Clinical Research with Janet Koontz

Heart of the Trial

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Join the always energetic Suzanne Turner as she dives into the intricate world of drug safety with industry veteran Janet Cummins! With over 20 years of experience, Janet shares her journey from a high school vocational tech class to becoming a director in pharmacovigilance. Get ready for a whirlwind tour of what really goes on behind the scenes in clinical trials.

Janet brings a wealth of knowledge and a healthy dose of humor to topics like adverse events, regulatory requirements, and the unexpected twists and turns in drug development. Did you know that a hypertension study led to the creation of Viagra? Or that some participants in trials have had their stool samples sent all the way to Switzerland? These are just a few of the fascinating stories you'll hear.

In this episode, Suzanne and Janet discuss:

• The nitty-gritty of drug safety and pharmacovigilance.
• Janet’s unconventional path into the industry and her passion for ensuring drug safety.
• The importance of regulatory bodies like the FDA and their impact on clinical trials.
• Hilarious and surprising moments from Janet’s extensive career, including a clinical trial involving gas collection in jars!

Whether you're an industry insider or just curious about the human side of healthcare, this episode is packed with insights and entertainment. Janet’s enthusiasm and Suzanne’s engaging hosting style make for a compelling listen that sheds light on the dedicated professionals working tirelessly to ensure the safety of new medications.

So, buckle up for an informative and fun ride through the trials and tribulations of clinical research. Tune in to discover the heart of the trial!

✨ Episode Highlights:

• [0:02] Suzanne welcomes listeners and introduces Janet Cummins.
• [1:20] Janet’s career journey and the role of pharmacovigilance.
• [10:35] Real-life anecdotes from clinical trials.
• [18:50] The evolution of drug safety and its regulatory framework.
• [30:00] Hilarious trial stories – from fart jars to unexpected drug effects.
• [45:15] Closing thoughts and contact information for Janet Cummins.

📞 Connect with Janet:

• Email: [e-mail] or [e-mail]
• Linkedin: https://www.linkedin.com/in/janetlkoontz/
• Phone: [phone]

📞 Connect with Suzanne:

• Website: https://www.iceconsultingllc.com/home
• LinkedIn: https://www.linkedin.com/in/turnersuzannem/

💌 Feedback and Questions:

• Email Suzanne at [e-mail]

🎙️ Tune in and get to know the passionate professional behind Heart of the Trial!