irfan sohail
TRANSCRIPT
Regulatory Affairs
The regulatory profession is vital in making safe and
effective healthcare products.
Regulatory Affairs Professional
Assist to meet requirements established by regulatoryagencies in introducing new product to market.
Employed in:
• Healthcare Companies
• Regulatory Agencies
• Contract Research Organizations
• Independent Consultants
Strategic Planning
Evaluate the regulatory environment and provide internaladvice throughout the product lifecycle
Perform risk/benefit analysis on product developmentconcept for initial product viability
Evaluate feasibility of safety and efficacy testing tocomply with regulatory standards
Strategic Planning
Provide regulatory intelligence to develop local,regional and global regulatory strategies
Identify appropriate regulatory authorities forsubmission of data and approval
Anticipate regulatory obstacles and provide alternativestrategies
Develop and review SOPs for regulatory compliance
Pre-marketing
Advise stakeholders with regulatory requirements forquality, preclinical and clinical data
Prepare registration dossier and submit to appropriateregulatory authorities
Interact with regulatory authorities during review process
Monitor progress of regulatory review throughappropriate communication
Pre-marketing
Timely respond to regulatory authorities queries andobservations
Participate in developing a risk management system (e.g.,vigilance) to ensure regulatory compliance
Identify, monitor and submit applicable reports (e.g.,Serious Adverse Events) or notifications (e.g., changes inmanufacturing or test method)
Post-marketing
Ensure regulatory compliance of labeling
Ensure regulatory compliance of advertising andpromotional items
Submit notifiable changes to update product informationand/or instructions for use
Ensure SOPs compliance to handle complaints, recallsand vigilance reports
Post-marketing
Ensure regulatory aspects of product manufacturing,testing and distribution
Maintain licenses (e.g., manufacturing, registration,controlled substances, sale)
Ensure compliance of import/export requirements
Ensure adequacy of product traceability systems
Miscellaneous
Interfacing
Communicate and negotiate with regulatory authoritiesand stakeholders to facilitate regulatory compliance
Co-ordinate company presentations to regulatoryauthorities to facilitate regulatory compliance
Provide input on proposed legislation, regulations,guidelines and standards
Accompany inspection and audit teams as required
Interfacing
Maintain records of legislation, regulations, guidelinesand standards to support strategic planning
Review public communications, press releases etc. toensure regulatory compliance
Communicate with legal counsel when regulatory bodyexceeds its authority
Regulatory Core Competencies
• Scientific or Technical background
• Experience is a key asset for Regulatory Professionals
• Soft skills e.g., Communication, Problem solving &Decision making, Project management, Leadership etc.
• Continuing Education and Professional Development
• Up to date with Regulatory Policies and Procedures
Regulatory Core Values
Regulatory Compliance
Competency
Objectivity
Integrity
Honesty
Courage
Fairness
Respect
Development of RA Professional
Level I (Officer/Executive)
• Have basic knowledge and understanding ofregulatory requirements, legislation and processes.
• Coordinate and support in technical and scientificregulatory activities.
• Develop soft skills such as writing, project coordinationand interpersonal communication.
Development of RA Professional
Level II (Asst. Manager/Manager)
• Have integrated understanding of regulatory affairs as itapplies throughout the product lifecycle.
• Strong emphasis on technical aspects of the professionand project management.
• Expand its involvement in international regulatory issuesand regulatory strategies.
Development of RA Professional
Level II (Asst. Manager/Manager)
• Develop knowledge and skills in areas such as:
• regulatory pathways and options;
• risk-benefit analysis;
• communication and collaboration internally andexternally;
• submission, obtaining approval, documentation,compliance, vigilance;
Development of RA Professional
Level III (General Manager/Associate Director)
• Have strong technical and management skills and activelyengaged in regulatory strategy, business activities andorganizational management.
• Develop knowledge and skills in areas such as:
• Strategy development, Risk assessment andmanagement;
• Monitor change in the regulatory environment,Influence the regulatory environment;
• Staff development and management;
Development of RA Professional
Level IV (Director/Chief Regulatory Officer)
• Proactively develop innovative approaches for pursuingbusiness objectives within the regulatory framework.
• Strategic planning and interfacing throughout theproduct lifecycle.
• Engaged in policy development .
• Typically are leaders and mentors within theirorganization and for RA Profession.