Under RAPS

10 June 2013

RAPS DC/Baltimore Chapter Career Day Offers Insight, Opportunity to Meet Employers

By Kathie Mantine

The RAPS DC/Baltimore Chapter Career Day, 11 May 2013, provided valuable insight into entering and working in the regulatory field, as well as an opportunity to speak with potential employers.

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30 May 2013

Adaptive Clinical Trials Likely to Increase; RAPS Program to Cover Regulatory Requirements

By Zachary Brousseau, senior manager, communications

Adaptive design clinical trials can give sponsor companies the flexibility to make changes to a trial in progress without compromising the validity of its findings, but also present unique challenges. Regulatory Focus spoke to experts participating in an upcoming RAPS virtual program on adaptive trials and their regulatory requirements about their benefits, potential pitfalls and FDA expectations. [Read More...]

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18 April 2013

RAPS Executive Development Program Gives Regulatory Pros Needed Business Foundation

By Zachary Brousseau, senior manager, communications

Increasingly, regulatory professionals are involved in making organizational business decisions, yet few have formal business training. RAPS’ Executive Development Program was designed to help them hone their business, management and leadership skills. [Read More...]

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4 April 2013

Helping to Lead the Regulatory Profession as a Leader, Mentor and RAPS Board Member

By Qyana Stewart

The Regulatory Affairs Professionals Society (RAPS) has, since its founding 1976, been the preeminent group representing regulatory affairs professionals involved in the regulation of healthcare products. With support from a dedicated professional staff, RAPS is led by 13 highly committed, distinguished and accomplished members of its board of directors.

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2 April 2013

Mastering the eCTD Format Critical for Regulatory Submissions Pros

By Zachary Brousseau, senior manager, communications

The electronic Common Technical Document (eCTD) provides a common global standard for companies to electronically submit the quality, safety and efficacy information required by regulatory agencies. It is an EMA requirement and will soon be required by FDA, so anyone working on drug regulatory submissions needs to understand the format well. [Read More...]

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21 March 2013

RAPS Award Winners Reflect on Importance of Regulatory Profession and Giving Back

By Zachary Brousseau, senior manager, communications

Regulatory Focus reflects on the 2012 RAPS awards honorees and the awards they received.

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27 February 2013

RAPS Congratulates 338 Regulatory Professionals Who Earned RAC in Autumn 2012

By Zachary Brousseau, senior manager, communications

RAPS has announced the names of the 338 regulatory professionals who earned their Regulatory Affairs Certification(RAC) during the autumn 2012 RAC exam period. [Read More...]

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27 February 2013

"I'm In Regulatory Affairs. Why would I want business training?"

By William C. Putnam, PhD, RAC

You are the senior regulatory professional in the board room overseeing a major development program. The program looks promising and all you need to be concerned about is the most [Read More...]

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25 February 2013

FDA Final Rule on Manufacturing of Combo Products Likely to Answer Some Questions, Raise Others

By Zachary Brousseau, senior manager, communications

FDA recently released its final rule on current Good Manufacturing Practices for combination products. The rule is likely to clarify some questions and raise others. A workshop hosted by RAPS and the Combination Products Coalition will examine the rule and FDA’s plan for implementation.

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20 February 2013

Risk Management: What Regulatory Professionals Need to Know

By Zachary Brousseau, RAPS senior manager, communications

Regulatory Focus caught up with William K. Sietsema, PhD, co-editor of Risk Management Principles for Devices and Pharmaceuticals: Global Perspectives on the Benefit: Risk Assessment of Medicinal Products, for his perspective on risk management principles and how the book addresses them. [Read More...]

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