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We can learn a lot about today's regulatory environment as a whole if we take it all in.
Four months ago, the staffs of eight Advanstar pharmaceutical and science magazines met to plan out the Pharmaceutical Regulatory Guidance Book, the group's first joint issue. We aimed to publish articles about the regulatory environment and how it affects the daily activities of our combined audiences who work throughout the entire pharma industry from the lab to postapproval marketing. The results of our efforts are packaged with our July issues, including Pharm Tech's.
I had the opportunity to serve as managing editor of the supplement and read all the articles before publication. When the articles were laid out together, I was surprised to find themes that ran through all the book's four sections (instrumentation, clinical trials, manufacturing, and marketing and sales). The clinical trials editor wrote about manufacturing processes and sales tactics. And, most authors reacted to the recent flurry of regulatory activity and development costs and pipeline challenges.
I guess I was caught up in the manufacturing silo, rather than seeing the industry as a whole. When press agents call about the latest FDA decision affecting direct-to-consumer advertising, I admittedly rush them off the phone saying, "Sorry. We don't cover that." But, many changes in the regulatory climate affect the entire industry. Because of the public's concerns about patient safety, for example, sales, clinical trials, and quality assurance teams alike face additional standards to protect patients' safety and control how they present their products to the public.
Though it's sometimes hard to see the forest for the trees, we can learn a lot about industry as a whole if we take it all in. I hope readers, too, will not only flip to the sections that directly affect their work, but also read what's happening in other industry segments.
Kaylynn Chiarello-Ebner is the managing editor of Pharmaceutical Technology, firstname.lastname@example.org