Feature articles in August covered the changing role of regulatory professionals including critical thinking and leadership skills, professional development strategies, the importance of obtaining professional qualifications and techniques for transitioning roles in a contract research organization. Other articles covered eCTD submission management, FDA’s TRG Rapid Inquiry Program, an overview of administrative law and considerations for implementation of a companion diagnostic. These articles plus the Q3 Regulatory Focus Article Series
on regulatory leadership and management were released in August.
Career Development and Professional Growth
Many national governments today have policies in place to foster growth of the medical technology and biopharmaceutical industry to contribute to the new knowledge economy. As the industry grows, organizations continue to face increasing pressure to find and retain talented and suitably qualified staff across a range of functions involved in the discovery and development of new therapeutics. Associate professor, Orin Chisholm,
discusses the benefits of formal qualifications for a regulatory career and highlights some of the English-language Master’s-level courses offered globally in “Professional Development: Benefits of Obtaining Professional Qualifications
In the pharmaceutical industry, working in the regulatory field offers many possibilities for horizontal career changes. Depending on one’s experience and goals, one may be able to fit into any number of niches with many opportunities to move between different areas of focus, even without specific experience in the area you may be interested in entering. Senior regulatory affairs associate, Kate Forte
, shares her personal experience in “Transitioning Between Medical Writing and Regulatory Affairs in a Contract Research Organization.
” She summarizes both roles and presents the similarities and differences between these two areas.
The regulatory profession has experienced an exciting evolution over the past few decades. Increasingly complex products, corporate structures and regulatory environment have created a demand for highly skilled regulatory leaders. Their roles have enhanced in importance and stature over the years and have now been recognized as a key strategic role. Many are now represented at the C-suite levels in organizations. In “Critical Thinking and Leadership Skills for Regulatory Professionals
,” regulatory and quality expert, Robert Yocher
, presents various sets of often underemphasized skills required for a successful regulatory professional career. Every person at every level can use them every day.
An initial marketing application submission is a major undertaking requiring a large team, numerous tools and a litany of subprocesses to work together in harmony for a successful outcome. Leaving any of this to chance is likely to result in missed timelines and excessive crunch time. With thorough planning, careful execution and the ability to navigate unexpected challenges, the odds of success can be greatly improved. In “eCTD Submission Management
,” regulatory operations manager, Ryan McNeely,
presents a high-level walkthrough and important considerations when planning an electronic Common Technical Document (eCTD) submission.
In June 2019, FDA introduced the new Tissue Reference Group (TRG) Rapid Inquiry Program (TRIP) which will be an expeditious, temporary alternative to the TRG inquiry, Request for Designation (RFD) and Pre-RFD processes through the Office of Combination Products (OCP). Senior regulatory affairs associate, Ashley Clark,
highlights the principal goal for this program in “FDA Announces new TRG Rapid Inquiry Program
.” Clark covers how the TRIP program is designed to work and explains elements of its regulatory changes under the Code of Federal Regulations, Title 21 Part 1271: human cells, tissues and cellular and tissue-based products (HCT/Ps). She describes product registration requirements and exceptions and highlights the program’s multiple benefits.
Senior consultant, Yingying Liu,
summarizes key points in “China’s State Council Publishes Updated “Measures” for the Administration of Human Genetic Resources
” published by the Peoples’ Republic of China’s State Council and currently available only in Chinese. The author reviews the first three of six chapters in the new document and the revised and updated “Measures” as applied to defining “human genetic resources.” Liu discusses the regulations imposed by China’s Human Genetic Resource Administration for human genetic resource collection and management as well as the effort to speed the approval of clinical trials using human genetic material.
The importance of understanding the impact of the administrative process on the regulated industry is critical as is the impact the federal rules and regulations can exert on the regulated industry. Yet, due process is provided to industry as the regulatory affairs professional has the unique opportunity to comment and submit petitions as it relates to the company the professional represents. In “Administrative Law Overview
,” legal expert, Roseann Termini,
provides an overview of federal administrative processes as they relate to the regulatory professional. Termini focuses on the Administrative Procedures Act
) and reviews the APA
impact on federal agencies, which must adhere to the Act’s
prescribed provisions in terms of legal procedures when publishing proposed rules which includes public participation in the rulemaking process by submitting comments about a proposed rule.
The drug development process in the US is extremely long and costly and it is critical to get patients drugs that are going to work for them. The goal of companion diagnostics is to work in combination with the drug to provide information so patients have access to the right drug at the right time in a cost-effective manner. The pursuit of a Companion Diagnostic (CDx), based on stratification to identify the most effective biomarkers, can reduce both drug development time and clinical trial sizes and facilitate more rapid regulatory approvals and time to market. Similarly, demonstrating the drug works with a select population of patients and a CDx can demonstrate a higher likelihood of identifying those patients encourages payers to minimize access barriers for that population. In “Considerations for Development and Implementation of a Companion Diagnostic
,” regulatory experts, Kennon Daniels
and Karen Richards,
discuss four key topics any pharmaceutical company should consider for development and implementation of a Companion Diagnostic (CDx) for use with oncology drugs or biologics.
What’s Coming in September?
September brings together global subject matter experts with an update on the latest developments on MDR and IVDR. Individual articles will cover implementation of IVDR and MDR into national legislation; what EU MDR means for substance-based medical devices; incorporating clinical evaluation requirements into the design and development process under MDR; challenges in clinical evaluation for the EU versus China; contractual and QMS driven implementation of shared medical devices regulation economic operator resources; the essential IVDR and the challenges it presents; UDI and labelling compliance under EU-MDR and EU-IVDR and PMS and PMCF for EU-MDR. Look for these articles throughout September.
Regulatory Focus – Call for Articles November 2019
is looking for subject matter experts to write articles for November featuring global regulatory implications of big data and digital health.
The term “big data” has been around for some time now, but there is still quite a lot of confusion about what it actually means. As applied to the pharmaceutical industry, big data are being used to evaluate the safe and effective use of medicines in the marketplace
Individual article topics could include:
- What is big data, how can it be used, who is using it and what does it mean for regulatory professionals?
- How will a regulatory professionals role and responsibilities change? SOPs?
- Are regulatory requirements changing?
- How will the utilization of big data impact the regulatory industry?
- How is FDA using big data to proactively monitor the safety of medical products after they have reached the market complementing the agency’s existing Adverse Event Reporting System.
- Global implementation strategies for obtaining/using/securing electronic healthcare data.
- Case studies on how electronic healthcare data is being incorporated into a company’s global regulatory strategy
- How is the pharmaceutical industry going to leverage big data in the coming years and how will it be implemented into its regulatory strategy?
- Compare or describe EMA and EDA approaches to the use and interpretations of big data
- How do regulatory agencies in Asia view big data? South America? Other regions?
- How to establish a protocol review committee for observational research using big data?
Consumers and healthcare providers are increasingly relying on digital health technologies to inform decision making. Digital health products have the potential to transform patient care.
Individual article topics could include:
- Software as a medical device
- Medical device interoperability
- Regional similarities and differences in regulation of digital health products
- Regulation of specific types of digital health products such as wearables, digital surgery devices, and mobile medical apps for example
- Clinical quality in digital health
- New and emerging regulatory models for digital health
- The convergence of digital health with existing product categories and how regulation might support or hinder this convergence
- Case studies on the regulatory approvals of a digital health product, including details on the regulatory approach taken, hurdles or barriers overcome
The submission deadline is 7 October 2019.
If you are interested in submitting an article for November or have a topic recommendation, email Gloria Hall at firstname.lastname@example.org