Leading in the Field of
Regulatory Affairs
Eric D. Kupferberg, PhD
Senior Fellow
25 July 2013
1
Basic Definition of the Field
• The essential steps and considerations necessary
for a company to gain approval from a regulatory
agency for the commercialization of biomedical
product
• The central focus is on the mechanisms and
criteria enlisted to show safety and effectiveness
of a product and its prescribed usage
2
Why Do We Need Regulatory Leaders?
• Statutes are outdated and vague
• Guidance documents are non-binding
• FDA approvals, audits, and letters are geared
toward particular products and companies
• FDA regulations DO NOT define how to
achieve compliance
• Regulatory approval is a nuanced and
negotiated act
Regulatory Stages for New Drugs
Respond to Shomen Chosa Q’s
FMA Audit
& Approval
FMA
Appl.
PMDA
intro
Meeting
Dossier
PreCons
Meeting
Preclin
Shomen
Chosa
Shomen
Chosa
Appl
3
Respond to
2nd Sen.
Kyogi Q’s
Clinical
Shomen
Chosa
Jichi
chosa
Shomen
Chosa
Approv.
Resubmit
STED
Request
2nd Sen.
Kyogi
2nd
Senmon
Kyogi
Reimb.
Appl’n
Reimb.
Aproval
Final
Product
Approval
PMSS
proposal
6
Submit
MAH
Request
Senmon
Kyogi
Submit
STED
1
GMP
Audit
Sub’s
2
GMP
Audit
approvals
Respond to GMP
Audit Questions
Respond to dossier technical questions
1st
Senmon
Kyogi
Respond to
Senmon
Kyogi Q’s
4
Resubmit
STED
Y-Kai
Meeting
Bukai
Meeting
Product
marketing
Approval
Sashi
-kai
Respond to
Bukai Q’s
5
Six critical sub-strategies of the Japan approval process
5
What Are the Basic RA Functions
• Primary function = regulatory compliance
• Day-to-day job is paper work
• Must have knowledge of existing statutes and
regulations
• Must design careful documentation systems for
all steps of approval
• Biggest challenge = Regulatory filing and audit
6
What is the Intermediate RA Work?
• Guide product through entire life-cycle,
including clinical trials, approval, labeling,
marketing, and post-market surveillance
• Manage products “across” business units,
including legal department, QA/QC, marketing,
finance
• Agility in working with teams and communicate
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The Life Cycle of Biomedical Products
What is Advanced RA Work?
• Proficiency in several technical areas,
including science, medicine, policy analysis,
economics
• Ability to accommodate development of new
product areas (e.g., nanotechnology,
combination products, tissue engineering,
genetic therapy)
• Strong leadership skills, even without formal
authority
What is Advanced RA Work?
• Interpretation of international regulations
and understanding of trade issues
• Lobby governments for changes in
regulations, laws, and health policies
• Work with investors and executives
• Ability to create sustainable competitive
advantages for host organization
Crucial Role of “Regulatory Strategy”
• Business strategy = deciding where you would
like to take your company and the best ways
to get there
• Many core strategic decisions are really
regulatory decisions
• Ability to identify process gaps and create
new processes
• Difference between avoiding losses and
maximizing cost-effectiveness of resources
Crucial Role of “Regulatory Strategy”
www.priory-analysts.com/uploads/images/Business_system_chart_02.JPG
How to Break into the Field
Where do RA leaders “come from”?
• Chemistry
• Engineering
• Pharmacology
• Quality
• Toxicology
• Writing
• Clinical sciences
• Management
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Problem with Learning “On the Job”
• Knowledge is limited to what the company currently “does” not
what it might “want to do” or what it will “have to do”
• Reproduce isolation of regulatory affairs
• Under-prepared for mergers and acquisitions
• Limited ability to advance the profession through research &
publications
First Steps to Take
• Develop skills and experience in one of the sciences that contribute
to product development, manufacturing and marketing (most
difficult part)
• Learn the regulations that apply to the company’s products
• Take courses that provide instruction in applying the regulations in
industry
• Join Regulatory Affairs Organizations
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Northeastern University- MS in Regulatory Affairs for
Drugs, Biologics & Medical Devices
•
Nearly all 44 courses are offered online and on-campus (Boston, Seattle, Charlotte)
•
Equal focus on medical devices and drugs
•
Broad curriculum on international topics
•
Unique emphasis on regulatory strategy, not just regulatory compliance
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CURRICULUM
Curriculum – Core Courses
6
4
Specialized Elective Courses
1
6 Core Foundation Courses
11
Core Courses
Open Elective Course
Total Courses
1.
Introduction to Drug and Medical Device Regulation
2.
Human Experimentation: Methodological Issues Fundamental to Clinical Trials
3.
New Drug Development
4.
Medical Device Development
5.
Biologics Development
6.
Food, Drug, and Medical Device Law
*Note: Students may be required by the department to take RGA6280: Advanced Writing on
International Biomedical Topics as a condition of their continued enrollment in the program
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CURRICULUM
Curriculum – Elective Courses
6
4
Specialized Elective Courses
1
4 Specialized Elective Courses
11
Core Courses
Open Elective Course
Total Courses
Choose one course from each of the following areas
•
1 Safety and Surveillance Course
•
1 Business and Law Course
•
1 Development and Strategy Course
•
1 International Regulatory Affairs Course
1 Open Elective Course or co-op/internship
•
Students may choose 1 additional course from any elective course category or a co-op or
internship
•
In order to participate in a co-op/internship all regulatory affairs students must complete the
following courses:
– RGA 6100 Introduction to Drug and Medical Device Regulations
– BTC 6210 Human Experimentation
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The Application Process
Visit https://app.applyyourself.com/?id=NEU-CPS
You will need to provide:
•
Original Personal Statement (500-1000 words)
•
Current resume
•
2 recommendations
•
Undergraduate official transcript
–
Sent directly from your undergraduate
institution to Northeastern
•
TOEFL/IELTS for non-native English speaking
students
•
You do not need to submit GRE/GMAT scores
•
Send your questions to: cpsadmissions@neu.edu or
call 877-668-7727
Already submit your application? Visit www.cps.neu.edu/admissions
The next start date: September 9, 2013
Visit www.cps.neu.edu/admissions for additional information
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