Professional Documents
Culture Documents
Regulatory Affairs
Regulatory Affairs
P.ANNAPURNA
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Regulatory Affairs Overview
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Regulatory Affairs Overview
Regulatory affairs professionals Works with
federal, state, and local regulatory agencies and
personnel on specific issues affecting their
business. i.e. working with such agencies as the
Food and Drug Administration or European
Medicines Agency (pharmaceuticals and medical
devices);
The regulatory function in healthcare industries is
vital in making safe and effective healthcare
products available worldwide.
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Regulatory Affairs Overview
Individuals who ensure regulatory compliance and
prepare submissions, as well as those whose
main job function is clinical affairs or quality
assurance are all considered regulatory
professionals.
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Regulatory Affairs Overview
Core Competencies
Regulatory professionals come from diverse
backgrounds. Most regulatory professionals have
earned a bachelor's degree, and more than half
have an advanced degree, most often in a scientific
or technical field. In addition, regulatory
professionals usually have experience in other
careers before transitioning into regulatory affairs.
Continuing education and professional development
are critical to the regulatory professional. Regulatory
professionals must keep up to date with regulatory
policies and procedures for one or more countries,
as well as maintain an understanding of the scientific
and technical background of healthcare products.
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Regulatory Affairs
Knowledge
• Regulated Countries
• Semi-regulated Countries
• Non-Regulated Countries
• Stability
• Technology transfer
• Validation
• Documentation
• Bioavailability and Bioequivalence studies (BA & BE)
• Patents 1
Regulatory Affairs
Knowledge
• REGULATED MARKET: The regulated pharmaceutical
markets are those markets where drug approval
processes are very strict. They follow intellectual
property regulations which are harmonised with
regulatory authorities (FDA, EU/EMEA) procedures,
with strict patents, pricing and other regulatory rules.
e.g. USA, Europe, Japan, Australia, Finland.
• SEMI REGULATED MARKET: Where regulatory
requirements are relatively less stringent than
regulated but more stringent than non regulated
markets.
e.g. GCC Countries, Maxico, Brazil, CIS countries
(Russia, Ukraine etc.) Indonesia, Malaysia etc.
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Regulatory Affairs
Knowledge
• NON REGULATED MARKET: Where regulatory
requirements are very simple.
e.g. Pakistan, India, SriLanka, Kenya, Cambodia,
Bangladesh etc.
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Regulatory Affairs
Drug applications
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REGULATORY AFFAIRS
CTD
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Regulatory Affairs
Regulatory Authorities
USA- USFDA (United States of Food and Drug
Administration)
Australia- DHAC (Department of Health and Aged
Care) TGA (Therapeutic Goods Administration)
European Union- EMEA (European Medicines
Agency)
Procedures for dossier submission in European
Union.
National Procedure
Decentralized Procedure
Mutual Reorganization Procedure
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METABOLISM & PHARMACOKINETICS
Contd..
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PHARMACOLOGY
• Responsibilities:
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CURRENT INDUSTRY OPINION
• Pharmacy Graduates / Post Graduates
Under equipped :
Lack of Exposure on :
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PHARMACY CURRICULUM
YES
Documentation of Processes
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NEED OF THE HOUR
Contd..
• Acquaint the pharmacy students in:
• Quality Management
• Regulatory Management
• Discovery Research.
• Disease Management
• Clinical Pharmacy:
• Patho-physiology
• Total Parenteral Nutrition
• Pharmaco-therapeutics
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NEED OF THE HOUR
Contd..
• Acquaint the pharmacy students in:
• Methods of Analysis
• Scale up techniques,
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NEED OF THE HOUR
Contd..
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SOFT SKILLS :
1 Commitment.
1 Ownership Feeling
1 Planning.
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ADVISE TO FACULTY
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ADVISE TO FACULTY
• Workshops
• Seminars
• Guests Lectures
• Visits to the Industry
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GOOD PHARMACY EDUCATIONAL
PRACTICES
To name a few :
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GOOD PHARMACY EDUCATIONAL PRACTICES
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JUST REMEMBER
IT IS ALWAYS AN OPPORTUNITY
IT IS WE WHO CONVERT
OPPORTUNITIES INTO THREATS
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