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1 April 2014

The Five Stages of Submissions

By Anonymous

Elisabeth Kübler-Ross identified the five stages of grief as denial, anger, bargaining, depression and acceptance. Regulatory submissions are really no different. [Read More...]

28 March 2014

“Let’s Play Ball:” One Regulatory Reviewer’s Guide to Effective Teamwork

By Victoria Hui, PharmD

Baseball: America's favorite past time, and strikingly similar to the world of pharmaceutical advertising and promotion. [Read More...]

26 March 2014

Transforming Temporary Resourcing into Strategic Resourcing

By Jennifer Thayer, MBA, MA, EdM, and Jason Falchuk

This article shares some tools for temporary resourcing the authors have leveraged over the years that can be helpful for hiring managers as well as individual contributors. [Read More...]

14 March 2014

Adding External Resources to Global Teams

By Rosalie Cull, PhD

This article provides a perspective on the inclusion of regulatory consultants and contractors in global pharmaceutical product development and commercialization teams. [Read More...]

20 February 2014

Diversity of Thought - a Key Ingredient for Regulatory Success

By Moulakshi Roychowdhury, PharmD, JD

Many corporations (including pharmaceutical, biotech and medical device companies) have spearheaded initiatives in support of diversity and inclusion, especially with respect to gender and ethnicities, to ensure fair and equal treatment of employees as well as corporate success. However, true diversity goes beyond aspects that are superficially apparent, beyond gender and ethnicity, to the distinct ways in which people inherently think. [Read More...]

29 January 2014

The Future of the Regulatory Profession–A Highly Educated Talent Pool

By Sylva Krizan, PhD

In this article, author Sylva Krizan discusses obtaining an advanced degree before beginning a career in regulatory affairs, and in particular advanced degrees in regulatory affairs.

[Read More...]

24 January 2014

The Ethics of Regulatory Mandates for Pediatric Research

By Christopher J. Leintz, MPH, DBe

While the efficacy of pediatric research regulations in the US and EU can be debated, ancillary ethical issues have arisen that need to be addressed. [Read More...]

26 November 2013

Participation of Women in Clinical Trials: Ethically Achieving Representative Enrollment

By Katherine St. Martin

Twenty years have passed since progressive regulatory agencies first attempted to reverse discriminatory attitudes against inclusion of women in studies, yet today they remain underrepresented in medical areas responsible for the highest risk to the female population. This article explores the lingering issues behind the slow adoption of representative enrollment. [Read More...]

18 September 2013

A Regulatory Internship: Is It Worth It?

By Faraz Khan

Budding regulatory professionals may want to consider an internship during their university years to enhance their knowledge and improve their job prospects later on. Interestingly, few reports have been published on the subject of regulatory internships, so this personal account may help guide the undecided by providing insights on merits and downsides.

[Read More...]

2 September 2013

A (Technologically Stunted) Ad/Promo Reviewer Looks at Techy Solutions to Regulatory Issues

By Moulakshi Roychowdhury, PharmD, JD

Let’s face it, regulatory advertising and promotion reviewers are generally not a technologically savvy demographic. Provided here is a brief review of three technology vendors that appear to provide optimal solutions to regulatory problems. [Read More...]

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RF Today is Regulatory Focus' daily news brief. Each edition contains the top global regulatory news stories about pharmaceuticals, medical devices, biotechnology and more. Learn more