Under RAPS

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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31 January 2013

RAPS Fellows Share Experiences, Insight and Advice for the Next Generation

By Zachary Brousseau, RAPS senior manager, communications

RAPS Fellows are leaders by example. Their experiences, insights and advice are invaluable to those seeking to develop their regulatory careers. With that in mind, Regulatory Focus asked the current class of Fellows about their careers, their victories and their visions for the future. [Read More...]

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6 December 2012

Book Excerpt: Risk Management in the Future: Looking Into the Crystal Ball

By Tjeerd-Pieter van Staa

Pharmacovigilance has been defined by the World Health Organization as, “The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.” Pharmacovigilance (or risk management) should help to inform both healthcare professionals and patients, allowing them to make educated decisions when choosing a treatment.

[Read More...]

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