Timings: 10 AM to 2 P.M on Sunday            Duration: 10 Sundays

Fee: Rs 10,000

Or

6.30 A.M to 7.30 A.M (Week days) + 3 Hrs Sunday

Module I: Introduction to the Profession and its Overview

Introduction and general overview of Pharmaceutical Industry

Functions and types of dosage forms

Definitions and various departments in the Industry

Regulatory Affairs as a Profession and its importance

Code of Ethics of regulatory profession

Functions of Regulatory Affairs

Importance of QA ad its link with Regulatory Affairs

Origin of drug development process and filings

Innovation, Creativity and its role in drug development and filings

Importance of Regulatory Audits

Module II: Regulations in United States of America

About USFDA and their Mission

Code of federal regulations

Patents and Data Exclusivity

About NDA, ANDA and other filing Process

About the Paragraphs and simulation of Judgments

Module III: Regulations in European Countries

EU Commission

EMA including CHMP and CVMP

National authorities of other EU Countries

Centralized Procedure

Decentralized Procedure

Mutual Recognition procedure

Abridged Application Process

Guidelines and Eudralex

Biological Similars

Module IV: Regulations in Other Countries and Dossiers

DMF & CTD

Differences in EU and US regulations

Regulations in Canada and its filing Process

Regulations in Japan and its filing process

Modile V: Important and critical Notifications for all Regulatory Bodies

Importance of Stability

Warning Letters

Recalls

Guidelines basics covering all the regulations

Pharmacopoeias and their contents

Impurities

Bioequivalence and Bioavailability

Indian Regulations – Drugs and Cosmetics Act

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Regulatory Affairs its importance:

Pharmaceutical products are regulated in essentially every country of the world

These regulations are applicable to both the investigation and marketing of compounds.

Regulatory affairs professionals play pivotal roles in the development, approval and surveillance of safe and effective health products worldwide, ensuring compliance with applicable laws and regulations. Regulatory affairs professionals are key, but perhaps overlooked, players in drug development. They are the primary communications link between the company and agencies such as FDA, and they are responsible for keeping up with the increasing scope and complexity of regulations both here and abroad.

In the pharmaceutical industry, regulatory affairs professionals have expertise in the legal and regulatory environments, as well as in clinical research protocols. They are the primary interpreters of the laws and regulations for other members of the company's R&D, manufacturing, and compliance staff. Regulatory affairs professionals must have a thorough understanding of the complex set of regulations within which FDA operates: 21 CFR (Code of Federal Regulations), Sections 1 through 1299. They also need to be familiar with regulations promulgated by a whole range of agencies: the Environmental Protection Agency, Federal Trade Commission, Occupational Safety & Health Administration, and Drug Enforcement Administration

Regulatory Affairs Defined

Regulatory Affairs is a specialized profession within the pharmaceutical/biotechnology sector.

Regulatory Affairs oversees company compliance with regulations and laws pertaining to the manufacture, marketing and development of regulated products.

Regulatory Affairs acts as point of contact between the company, its products and regulatory authorities

Regulatory Affairs interacts with worldwide, federal, state, and local regulatory agencies (e.g., FDA (US), EMEA (EU), BfARM (Germany), TPD (Canada), etc) to assure…

 -licensing,

-registration,

-development,

-manufacturing,

-marketing and

-labeling

…….of pharmaceutical and medical products are conducted in compliance with all applicable rules 

Regulatory Framework

Development, approval for marketing, manufacturing, and ongoing compliance of pharmaceutical/biotech products is among the most regulated activities of any industry

Regulations are complex systems of interrelated rules that govern a broad range of activities

These rules are continuously undergoing amendment and supplementation

Their main function is to assure that these products are safe (do no harm) and effective    (do some good)

Regulatory affairs provide insight/guidance into this development through agency wisdom collected in guidance, previous experience, market precedence, etc.

Compliance with Regulator expectations therefore equates with development success. Patient Protection is of greatest importance

                Regulatory Affairs Duties & Functions

Advises and assists the Commissioner and other key officials on regulations and compliance-oriented matters that have an impact on Policy development and execution, and long-range program goals.

Coordinates, interprets, and evaluates the Agency's overall compliance efforts; as necessary, establishes compliance policy or recommends policy to the Commissioner.

Stimulates awareness within the Agency of the need for prompt and positive action to assure compliance by regulated industries; works to assure an effective and uniform balance between voluntary and regulatory compliance and Agency responsiveness to consumer needs.

Evaluates and coordinates all proposed legal actions to ascertain compliance with regulatory policy and enforcement objectives.

 Executes direct line authority over all Agency field operations, develops, issues, approves, or clears proposals and instructions affecting field activities; serves as the central point within the Agency through which Headquarters offices obtain field support services.

Provides direction and counsel to Regional Food and Drug Directors in the implementation of policies and operational             guidelines that form the framework for management of Agency field-activities.

Develops, and/or recommends to the Commissioner policy, programs, and plans for activities between the Agency and State and local agencies; administers the Agency's overall Federal-State program and policy, coordinates the program aspects of Agency contracts with State and local counterpart agencies.

Evaluates the overall management and capabilities of the Agency's field organization; initiates action to improve the management of field activities and coordinates the formulation and management of career development plans.

Directs and coordinates the Agency's emergency preparedness and civil defense programs.

Operates the Federal Medical Products Quality Assurance Program for the Agency

The RAPS Code of Ethics for Regulatory Affairs

Professionals is a living document that embodies the principles of professionalism and ethics to which regulatory professionals aspire and hold inviolable.

                                                      Codes of ethics

Regulatory professionals shall:

Have a primary duty to ensure our employer’s Activities are conducted in compliance with the laws and regulations of the authorities under which we operate, consistent with advancing, preserving and protecting public health.

Be competent to perform the services we have been hired or retained to perform. As regulatoryprofessionals we must commit ourselves to continual learning while being able to acknowledge areas that are outside of our expertise.

Act in an objective manner.  As regulatory professionals we must base decisions on factual information. We must not be unduly influenced by competing or conflicting interests.

Have integrity. As regulatory professionals we must be principled and consistent in applying our views. We must live up to our commitments, and be trust worthy and scrupulous at all times.

Be honest in all dealings with our employers and others with whom we interact. As regulatory professionals we must ensure that information and communications, whether oral or written, are accurate and complete. We acknowledge that personal and institutional credibility are crucial to our success.

Have the courage to make difficult decisions and present all relevant information to our organizations to promote wise decisions. As regulatory professionals we must be able to withstand challenges to our views, while at the same time be

accountable for our mistakes.

Be fair in our dealings with all parties. As regulatory professionals we must apply legal and regulatory standards equitably. We must be just in considering the interests of all parties in decision processes.

Be respectful of others, whether it is our peers, subordinates or external parties with whom we interact. We must treat all individuals with dignity and courtesy.

Duty:

Our role as regulatory professionals is defined by our duty to advise individuals and organizations regarding the appropriate regulatory context for actions they may want to take.

Our roles are further defined by our obligations as employees of companies that make important medical products for patients, as members of teams that conduct nonclinical and clinical studies, as regulators, and as members of our profession.

‘Regulatory professionals:

Have a primary duty to the unbiased dissemination and interpretation of relevant governmental regulations, industry standards and good practice guidelines.

Have a duty to our employers to ensure products are safe and beneficial to patients,

While maintaining the long-term interests of our employers.

Have a duty to those who participate in clinical studies and who use regulated products to ensure that, to the extent possible, the benefits justify the risks.

Have a duty to provide physicians and other healthcare professionals with accurate and complete information about the safety and Effectiveness of products.

Have a duty to our peers to maintain the long-term integrity of our profession and to strive to deserve the public’s confidence and respect.

Competence: Competence

Competence means that a regulatory professional has the knowledge, abilities and skills necessary to effectively identify, analyze and solve or recommend solutions to regulatory challenges.

Competent regulatory professionals lend credibility to the profession by demonstrating they have the knowledge, experience, dedication and flexibility to adapt to the ever-changing realm of the regulatory profession.

The diversity of individuals and organizational contexts within the regulatory profession necessitates Commitment to a standard level of knowledge. This standard may be achieved through a variety of means: Education, work experience, and professional training and certifications.

Just as the regulatory profession continues to evolve, maintaining competence within the field is a continual learning process.

Regulatory professionals:

Seek to remain informed and knowledgeable about current and future trends.

Avoid claims of competence in any area in which they do not have a thorough understanding .

Encourage and support opportunities for professional growth and development among peers and subordinates so that all who work in the field can gain and demonstrate competence in the profession.

Objectivity:

Objectivity is treating or dealing with facts without distortion by personal feelings or biases.

Regulatory professionals must be objective. Although the regulatory professional must evaluate information from several points of view, he/she must rely on a basic understanding of facts.

The interests of a number of parties may be affectedly decisions made by regulatory professionals. These include the company, regulators, healthcare professionals,  patients and shareholders, all of whose interests may be served differently and, in some cases, in a contrary fashion. Regulatory professionals need to be cognizant of these interests without letting them unduly influence their final actions.

Regulatory professionals:

Respond carefully to an opinion issue, recognizing that there is rarely a single right or wrong answer Opinions can often take on a partisan perspective. Caution must prevail and guide the professional to offer an unbiased expression of facts.

Present all reasonable regulatory options and associated risks when developing regulatory strategies.

Clearly differentiate among regulatory requirements, internal requirements and personal preferences.

Disclose new information appropriately with the proper context.

Integrity:

Integrity is a commitment to a set of values. Individuals with integrity are principled, scrupulous and trustworthy. Having integrity suggests that one s “whole,” that one’s beliefs, words and actions are congruent and consistent.

Regulatory professionals with integrity will not compromise their values or trustworthiness for personal gain or professional enhancement.

Regulatory professionals:

Live up to commitments.

 Give credit for the work of others.

Maintain the confidentiality of information, and never disclose information concerning the business or technical affairs of employers or clients without their consent.

Seek advice from another individual or group whose opinion they respect when uncertain.

When asked to compromise integrity for the sake of one party over another, reconsider their obligations and the long-term consequences of their actions.

Avoid being placed in situations that put their integrity at risk.

Hold strong to beliefs, recognizing that what they believe may be the best course of action may not be in the short-term interest of their employer.

Never accept compensation that is not earned.

Avoid conflicts of interest relating to employers or clients, or make them known when they are Unavoidable.

Honesty:

Honesty is understood as truthfulness, candor and sincerity. It requires a person to act in ways free from deceit or deception, including dishonesty by omission—failing to say something. Honesty requires one to be candid and forthcoming, not simply to refrain from false statements.

Regulatory professionals, in fulfilling their duty to patients, to their employer and to the profession, must exhibit honesty in all of their activities. Honesty builds trust, essential to fostering effective working relationships among regulatory authorities, the regulated industry, individual corporations and individual regulatory professionals.

Regulatory professionals:

Ensure any information provided to subjects, patients, healthcare providers, employers, regulatory authorities and consumers is accurate and complete.

Ensure there have not been significant omissions of information or false impressions implied.

Resist pressures to relax standards of honesty; for example, to achieve expediency.

Ensure that submissions represent a complete profile of the product under review.

Courage:

Courage is the act of choosing what one believes to be the right thing even when doing so is difficult.

Regulatory professionals must have the courage to evaluate, conclude, and provide consistent and accurate regulatory advice. They must have the courage to demand access to information that is required to do their job, and they must do their job as completely as possible, including advising stakeholders of potential risks. Regulatory professionals must have the courage to give bad news when necessary and to accept the consequences of their decisions.

There will be situations where regulatory advice needs to be retracted or corrected. The regulatory professional must have the courage to bring forth the error and accept accountability, where appropriate.

Regulatory professionals:

Review and reiterate their advice and strategy when necessary or when challenged, and change it when appropriate.

Ask for help when needed.

Encourage an open exchange of views that challenge regulatory advice.

Admit mistakes and take appropriate measures to promptly correct them.

Deliver bad news quickly to management.

Provide information about risks and consequences if regulatory advice is overruled or ignored.

Fairness:

Fairness means that all persons are being treated equitably. In particular, it includes the principle of treating all persons equally in accordance with the law and holding all those with common responsibilities to a common standard.

Regulatory professionals must consider the rights and needs of all parties affected by outcomes to which they contribute. This includes the wise consideration of laws, science and appropriate societal norms.

Regulatory professionals:

Respect the letter and spirit of governmental laws and regulations.

 Apply the appropriate legal and regulatory standards to all cases, taking into account cultural and regional differences and local requirements.

Present the facts and analysis of scientific information using sound statistical interpretation  that strives to minimize bias even while giving results that may contain some element of uncertainty.

Strive to ensure that the interests of all parties, public and private, are appropriately considered in decision processes.

 Respect:

Respect is the regard for or appreciation of the worth or value of someone or something.

First and foremost, regulatory professionals will respect the role of their colleagues. As regulatory professionals we must also be prepared to recognize and acknowledge the worth of all parties. This recognition demonstrates the belief that everyone has value.

 Regulatory professionals:

Listen to what others have to say in a fair and objective way.

 Refrain from embarrassing, ridiculing or hurting others in their actions or omission of actions.

Treat all parties, regardless of level or position, with dignity, civility and courtesy.

Accept that personal differences will occur, but work diligently toward finding a position that accommodates those differences.

Create a positive environment that encourages and promotes respect.

Share what they know in a non-intimidating way and are tolerant of those who do not initially understand.

Avoid conflict where possible. If not possible, find creative ways to resolve conflict in an effort to preserve a positive business relationship.

 Are patient and forgiving when others make mistakes and work to prevent the mistakes from recurring rather than assigning blame.

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What Regulators Look for?

Minimum current good manufacturing practice in manufacture, processing, packing, or holding of a drug to ensure

•         S          Safety      (free of any unexpected side effects)

•         I           Identity   (exactly what the label claims)

•         S          Strength  (delivers the correct dosage and potency)

•         P          Purity    (free from physical, biological and chemical contamination)

•         Q         Quality    (meets all standards and can be made  consistently)

    Failure to meet this requirements, shall render the drug adulterated

   as well as person responsible shall be subject to regulatory action.

All the Departments in Pharmaceutical industry:

Following are the departments required in the pharmaceutical industry to fulfill the all requirements

•         1.Quality Assurance

•         2. Quality Control

•         3.Production

•         4.Warehouse

•         5.Engineering

•         6.Formulation research & development

•         7. Regulatory Affairs

•         8.House keeping

•         9. IPM/IPR

Sequence of activities performed in the pharmaceutical industry

•         1. Facility construction as per proposed planner.

•         2. Testing area & manufacturing area qualification (validation) .

•         3.  All utilities qualification.

•         4.  Product development by FRD

•         5.  Vendor qualification for the material supply.

•         6.  Receive the qualified vendor material by warehouse.

•         7. Consume the materials by production & produce finished product.

•         8.  Material testing by Quality Control & release

•         9.   Dispatch the materials from warehouse to market.

Types of materials received in the warehouse:

•         1. Raw materials

•         2. Excipients

•         3. Primary packing materials

•         4. Secondary packing material.

Quality control release types

•         1. In-process material through in-process specifications.

•          2. Finished product through finished product specifications.

                           Note: Quality Control testing involves two types of testing

                            Quality control microbiology – Related to microbes

                      Quality control chemical - Related to chemicals testing

Validation Approach for Equipments in Facility

•         1. Installation qualification

•          2. Operational Qualification.

•          3. Performance Qualification.

•         Note: Factory acceptance test, Site acceptance test shall be performed at initial stages development.

•          

Basic Documents in Industry

•         1. Standard operating procedures - useful to guide the procedures which are followed.

•         2. Protocols: To execute the validation activity & record the results.

•         3. Batch manufacturing record / Batch packaging record: To instruct during manufacturing & record the results.

                                        Some important definitions

      QUALITY – Degree to which a set of inherent characteristics

         (Distinguishing features – inherent / assigned; qualitative /

         quantitative) fulfils requirements.

         QUALITY CONTROL – Operational techniques and activities that

         are used to fulfill requirements for quality.

         QUALITY ASSURANCE – All the planned and systematic actions

         necessary to provide adequate confidence that a product or service

         will satisfy given requirements for quality.

Concept & Objective of Building Quality Products

         “Building Quality into Products / Processes”.

         Documentation in form of procedures that facilitate the description of

      actions / tasks to be performed.

         Procedures that facilitate the traceability of the actions / tasks

      performed.

         Data & Records fulfillment to ensure that the procedures are being

      implemented.

         Procedures to ensure that data are protected from loss, damage, theft or  tampering.

      To provide a systematic base for all processes.

      To constantly upgrade / improve overall quality of the product /

      processes.

         To maintain a continuing assessment of the quality of product /

       processes.

         To address quality documentation in departments & processes.

         To ensure proper record keeping.

Quality Systems is divided into 7 divisions; with each division performing specific set of activities in order to ensure, we meet the requirements of our Pharma QUALITY MANAGEMENT SYSTEMS.

DIVISIONS:

        MANUFACTURING ASSURANCE

        VALIDATION ASSURANCE

        ANALYTICAL ASSURANCE

        STABILITY MANAGEMENT

        ENGINEERING ASSURANCE 

        DOCUMENTATION

        TECHNICAL TRAINING

Quick Summary of Quality and Regulatory requirements

      Everyone must be actively involved with quality everyday.

         QA is not something special, done periodically, but must be done every day

      on every activity.

         You are responsible for what you do.

         Keep records – don’t rely on memory

         Bad Data is worse than no data.

         Nothing is perfect.  Be aware of limit…. i.e. how good (bad) is the product

      / process.

         Opinions do not count – What are the facts?

         Quality problems are not fate.  They have causes and can be corrected.

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