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

Welcome
Presentation member
1.Asiful Alam id-1431405672
2.Mohammad Ariful Islam id-1331049673
3.MD ABU SHUAIB Rafshanjani ID-1321405673
Code of Ethics : DRA VS RPS

Welcome
The Code Of Ethics
Comparison Between
Drug Regulatory Affairs
and
Royal Pharmaceutical Society

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

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.

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.

Code Of Ethics Of Drug
Regulatory Affairs
 Duty
 Competency
 Objectivity
 Integrity
 Honesty
 Courage
 Fairness
 Respect

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

Overview Of Code Of Ethics Of
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.

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 trustworthy
Have 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.

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 something
Be 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.

7. Fairness : means that all persons are being treated equitably
Be 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.

1. MAKE THE CARE OF PATIENTS YOUR FIRST CONCERN
The care, well-being and safety of patients are at the centre of everyday
professional 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 PUBLIC
The 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.

3. SHOW RESPECT FOR OTHERS
Demonstrating 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 CARE
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.

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 and
maintains the reputation of your profession.

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

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.

Comparison
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
Honesty
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 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.
.

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
Fairness
Fairness : means that all persons are being
treated equitably
Be 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 CARE
RPS 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- India
USFDA- 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_Gr
eat_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/123456789/118254/5b5a252
06e034079a4dda2b8de3504b4.pdf?sequence=1

Thanking
you
Have a good
day………………. 29

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

Empfohlen

Empfohlen

Weitere ähnliche Inhalte

Was ist angesagt?

Was ist angesagt? (20)

Andere mochten auch

Andere mochten auch (20)

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

Ähnlich wie Comparison between code of ethics of drug regulatory authority and Royal Pharmaceutical Society (20)

Kürzlich hochgeladen

Kürzlich hochgeladen (20)

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