Comparison between code of ethics of drug regulatory authority and Royal Pharmaceutical Society

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Presentation member

1.Asiful Alam id-14314056722.Mohammad Ariful Islam id-13310496733.MD ABU SHUAIB Rafshanjani ID-1321405673 Code of Ethics : DRA VS RPS

Welcome

The Code Of Ethics Comparison BetweenDrug Regulatory Affairs and Royal Pharmaceutical Society

Code of Ethics : DRA VS RPS

Amjfn Pharmaceuticals Limited

Contents

Drug Regulatory Affairs (DRA)

Royal Pharmaceutical Society (RPS)

Code of Ethics of Drug Regulatory Affairs (DRA)

Code of Ethics of Royal Pharmaceutical Society (RPS)

Overview of Code of Ethics Of DRA

Overview of Code of Ethics Of RPS

Comparison Between Code of Ethics of DRA and RPS

Overview of Comparison Between Code of Ethics of

DRA and RPS

Recommendation

Reference


DRA

Drug Regulatory Affairs

Scope of DRA Research & Development/PD Investigational new drug application (INDA) New Drug Application (NDA) Abridged New Drug Application (ANDA) Pharmacovigillance (ADR Reporting system) Clinical trial & PMS Export: DRA compliance DRA & Commercial DRA & TRIPS

DRA, as the international leader for the healthcare regulatory profession, has initiated and supported the development of the code of ethics for the pharmacy profession. They identified eight core values that regulatory affairs professionals embrace.


RPhS


Royal Pharmaceutical Society

The Royal Pharmaceutical Society (RPS) is the body responsible for the leadership and support of the pharmacy profession within England, Scotland and Wales. It was created along with the General Pharmaceutical Council (GPhC) in September 2010 when the previous Royal Pharmaceutical Society of Great Britain was split so that representative and regulatory functions of the pharmacy profession could be separated.

ETHICS

Code Of Ethics Of Drug Regulatory Affairs

Duty Competency Objectivity Integrity Honesty Courage Fairness Respect


ETHICS

Code Of Ethics Of Royal Pharmaceutical Society


Make The Care of Patients Your First Concern Exercise your Professional Judgments in the Interest of

Patients and the Public Show respect for others Encourage patients to participate in discussion about

their care Develop your professional knowledge and competence Be honest and trustworthy Take responsibility for your working practices

ETHICS

Overview Of Code Of Ethics Of Drug Regulatory Affairs

1.DUTY : Have a primary duty to ensure 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.Our role as regulatory affairs professionals is defined by our duty to advise individuals and organizations regarding the appropriate regulatory context for actions they must want to take.

2.Competency : Competence means that a regulatory affairs professional has the knowledge, abilities and skills necessary to effectively identify, analyze and solve or recommend solution to regulatory challenges.Be competent to perform the services we have been hired or retained to perform. As regulatory affairs professionals we must commit ourselves to continual learning while being able to acknowledge areas that are outside of our expertise.


ETHICS


3. Objectivity : is treating or dealing with facts without distortion by personal feelings or biases.Act in an objective manner. As regulatory affairs professionals we must base decisions on factual information. We must not be unduly influenced by competing or conflicting interests.

4. Integrity : is a commitment to a set of values. Individuals with integrity are principled, scrupulous and trustworthyHave integrity. As regulatory affairs professionals we must be principled and consistent in applying our views. We must live up to our commitment, and be trustworthy and scrupulous at all time.


ETHICS


5. Honesty : is under 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 somethingBe honest in all dealings with our employers and other with whom we interact. As regulatory affairs 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.

6. Courage : is the act of choosing what one believes to be the right thing even when doing so is difficult.RA professionals must have the courage to evaluate, conclude, and provide consistent and accurate regulatory advice. Have the courage to make difficult decision and present all relevant information to our organizations to promote wise decision. As RA professionals we must be able to withstand challenges to our views, while at the same time be accountable for our mistakes.


ETHICS


7. Fairness : means that all persons are being treated equitablyBe fair in our dealings with all parties. As regulatory affairs professionals we must apply legal and regulatory standards equitably. We must be just in considering the interests of all parties in decision processes.

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


ETHICS

Overview Of Code Of Ethics Of Royal Pharmaceutical Society

1. MAKE THE CARE OF PATIENTS YOUR FIRST CONCERNThe care, well-being and safety of patients are at the centre of everydayprofessional practice. They must be your primary and continuing concern when practicing, irrespective of your field of work. Even if you do not have direct contact with patients your actions or behavior can still impact on their care or safety.

2. EXERCISE YOUR PROFESSIONAL JUDGEMENT IN THE INTERESTS OF PATIENTS AND THE PUBLICThe need to balance the requirements of individuals with society as a whole and manage competing priorities and obligations is a feature of professional life. Guidelines, targets and financial constraints need to be taken into account, but they must not be allowed to compromise your ability to make an informed professional judgment on what is appropriate for patients in specific situations.


ETHICS


3. SHOW RESPECT FOR OTHERSDemonstrating respect for the dignity, views and rights of others is fundamental in forming and maintaining professionally appropriate relationships with patients, their careers, colleagues and other individuals with whom you come into contact with.

4. ENCOURAGE PATIENTS TO PARTICIPATE IN DECISIONS ABOUT THEIR CAREPatients have a right to be involved in decisions about their treatment and care. They should be encouraged to work in partnership with you and other members of the professional team. Successful partnership working requires effective communication and an ability to identify the individual needs of patients.


ETHICS


5. DEVELOP YOUR PROFESSIONAL KNOWLEDGE AND COMPETENCE

At all stages of your professional working life you must ensure that your knowledge, skills and performance are of a high quality, up to date and relevant to your field of practice.

6. BE HONEST AND TRUSTWORTHY

Patients, colleagues and the public at large place their trust in you as a pharmacy professional. You must behave in a way that justifies this trust andmaintains the reputation of your profession.


ETHICS


7. TAKE RESPONSIBILITY FOR YOUR WORKING PRACTICES

Team working is a key feature of everyday professional practice and requires respect, co-operation and communication with colleagues from your own and other professions. When working as part of a team you remain accountable for your own decisions, behavior and any work done under your supervision.


Any Guesses?????

Comparison


Priority

Comparison


--- Highest Concern ---

Care of Patient is the first concern in RPS Ethics .But first concern for DRA ethics is to perform the duty properly to ensure that employer’s activities are conducted in compliance with the laws and regulations of the authorities under which they operate, consistent with advancing, preserving, and protecting public health.

RespectComparison


RESPECT FOR OTHERS

Respect for others are very important in both code of ethics . Both code of ethics discuss about the respect for others like their peers, subordinates or external parties with whom they interact. Professionals must treat all individuals with dignity and courtesy.

Comparison

HonestyPatients, colleagues and the public at large place their trust in you as a pharmacy professional. You must behave in a way that justifies this trust and maintains the reputation of your profession. Both code of ethics discuss about the honesty of Pharmacist .


Comparison


RESPONSIBILITY FOR YOUR WORKING PRACTICES

When working as part of a team you remain accountable for your own decisions, behavior and any work done under your supervision. So In RPS ethics, team working is preferable and all take responsibility DRA professionals Have the courage to make difficult decision and present all relevant information to our organizations to promote wise decision.RA professionals must be able to withstand challenges to views, while at the same time be accountable for their mistakes.

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Comparison


As regulatory affairs professionals we must commit ourselves to continual learning while being able to acknowledge areas that are outside of our expertise.

In RPS ethics , At all stages of your professional working life you must ensure that your knowledge, skills and performance are of a high quality, up to date and relevant to your field of practice.

DEVELOP PROFESSIONAL KNOWLEDGE AND COMPETENCE

Comparison


FairnessFairness : means that all persons are being treated equitablyBe fair in dealings with all parties. As regulatory affairs professionals must apply legal and regulatory standards equitably. must be just in considering the interests of all parties in decision processes.Fairness is including in the DRA ethics as one of the important ethics which is not found in RPS ethics

Comparison


ENCOURAGE PATIENTS TO PARTICIPATE IN DECISIONS ABOUT THEIR CARERPS ethics shows that Patients have a right to be involved in decisions about their treatment and care. They should be encouraged to work in partnership with you and other members of the professional team. Successful partnership working requires effective communication and an ability to identify the individual needs of patients.

DRA doesn’t show good idea about patient participate

Comparison


Objectivity : is treating or dealing with facts without distortion by personal feelings or biases.As regulatory affairs professionals people must base decisions on factual information. They must not be unduly influenced by competing or conflicting interests.Objectivity is not goodly discuss in RPS ethics

Comparison


Which departments are assisted by DRA department? Drug Regulatory Authorities (across the world) CDSCO- IndiaUSFDA- United States EMEA-(Europe, the Middle East and Africa)European countries MHRA- (Medicines and Healthcare products Regulatory Agency)United Kingdom TGA- Australia MCC- (Medicines Control Council) South Africa Product Development Clinical Research & Trials Licensing Quality Assurance & control Marketing

Recommendation


We Should follow both Code of Ethics as Both of them discuss about

many important factor and duties of Pharmacist .All of them are very

important for our proper activity. Both code of ethics provides

insight/guidance of development through agency wisdom collected in

guidance, previous experience, market precedence, etc. and hence helps

to reduce number of development failures.

Reference

http://www.rpharms.com/code-of-ethics-pdfs/coeppt.pdf

http://www.rpharms.com/support/mep.asp

http://en.wikipedia.org/wiki/Royal_Pharmaceutical_Society_of_Great_Britain

http://www.rpharms.com/home/home.asp

http://www.pharmacyresearchuk.org/waterway/wp-content/uploads/2012/11/Ethics_in_pharmacy_practice_200910.pdf

http://ir.nmu.org.ua/bitstream/handle/123456789/118254/5b5a25206e034079a4dda2b8de3504b4.pdf?sequence=1


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Have a good day………………. 29Code of Ethics : DRA VS RPS

Health & Medicine

Comparison between code of ethics of drug regulatory authority and Royal Pharmaceutical Society