Posted 01 August 2017
By Gloria Hall
Feature articles over the past several weeks highlighted regulatory affairs as a profession, including careers in regulatory advertising and promotion, possible pathways and career progression and resources and training for regulatory professionals. Other articles covered various types of inspections conducted by FDA and processes for cleaning validation in the pharmaceutical industry.
Faderan's exclusive interview with the president of Cook Research Incorporated (CRI), Jennifer Kerr, RAC, includes details of her wide range of responsibilities at CRI. The thoughtful discussion captures Kerr's strategic leadership viewpoint and highlights her hands-on and collaborative management style. The article also covers a wide range of other topics, from the executive's education, including how she became interested in regulatory, and some of her experiences in clinical affairs. Finally, Kerr provides a snapshot of her typical day, shares her strategy for keeping up-to-date with the continually changing regulatory environment, and offers recommendations for those individuals just starting out in the regulatory/clinical affairs field.
The Regulatory Advertising and Promotion (RAP) group within a pharmaceutical company is responsible for understanding and interpreting laws, regulations, codes and guidance that govern prescription drug advertising and promotion. Professionals in these positions require a thorough understanding of the regulatory landscape to ensure company compliance by providing strategic regulatory guidance for the company throughout the lifecycle of drug products. In her article, "Careers in Regulatory Advertising and Promotion," Huettenmoser provides an overview of RAP as a career in the pharmaceutical industry and discusses topics such as potential avenues for starting a career in RAP, qualities required to be successful and some general career advice, including information on, and the benefits of, participating in post-doctoral fellowship programs.
A regulatory department is a significant part of any pharmaceutical company and regulatory professionals can be involved in drug development processes from the earliest stages of drug development through post-approval activities. To gain this working knowledge of both the pharmaceutical industry and health authorities, many regulatory professionals start their careers as either interns or assistants. Kawiak and Patel explore common pathways for a career as a regulatory professional and possbile career progression from junior to senior to manager level in their article "Regulatory Career Progression." They summarize the skills required for each level and what it takes to move up the corporate ladder. They also describe the responsibilities of a regulatory professional in a senior management position.
In "10 Secrets to Regulatory Success," Savage shares her practical, real life experience on how to develop regulatory submissions. In addition to the importance of good writing, she emphasizes the benefits of being prepared and keeping your processes organized.
The pharmaceutical industry is one of the most highly regulated and complex industrial environments. As innovation is important and greatly supported by regulatory agencies, regulatory changes have opened up opportunities for subject matter experts to provide knowledge and contribute to the overall success of the pharmaceutical industry. For the regulatory professional, continuous training and learning are instrumental in keeping up-to-date on challenges and strategies resulting from these ongoing regulatory changes. In the article, "Resources and Training for Regulatory Professionals," Silva provides a progressive career path for regulatory professionals from the early stages through specialization. The author recommends a variety of ways to keep current on evolving regulatory issues, including on-the-job training, self-education via the Internet, attending conferences, networking, and membership in professional organizations.
Policy and Guidance
With growing agency interest, including increased oversight and expanded enforcement efforts, it is critical for the pharmaceutical industry to establish and maintain systems to ensure compliance with applicable laws and regulations and to remain inspection-ready at all times. In the article, "FDA Inspections and Outcomes for Oral Solid Dosage (OSD) Manufacturing Facilities," Arora explains various types of current Good Manufacturing Practice (CGMP) inspections conducted by FDA at oral solid dosage forms manufacturing facilities and elaborates on types of inspections, approaches to investigations, limitations of these inspections and major inspection outcomes in the event of deficiencies, including 483s, Warning Letters and Establishment Investigation Reports (EIRs).
Cleaning validation is the scientific process for demonstrating and documenting a chosen cleaning procedure works consistently and starts with designing a cleaning process, then proving the process works. Godshalk presents a look at pharmaceutical industry cleaning processes, cleaning validation and cleaning verification in his article "Pharmaceutical Cleaning Processes."
Feature Articles Coming Throughout August
Feature articles throughout the month of August will present risk management challenges in the medical device industry, bioequivalence studies of solid oral dosage forms, integrated scientific advice trends, global reimbursement environment from a drug perspective, and how wearable technologies and mobile health devices can impact reimbursement.
Look for these feature articles and more throughout August.
If you have a suggestion for a feature article, contact me at email@example.com.