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Advice You - Business Leadership Starts with Mentoring-The Dance of Mentoring
The typical role of a mentor is defined as being the training and technical support anchor for an individual who is learning new skills and knowledge. The mentor guides and leads their prot?g? in a dance that ensures knowledge and skills from the mentor are transferred to the prot?g?. This dance is individually cho
According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
reographed for each mentor and prot?g? as all prot?g?s’ are not the same.
One of the big mistakes systems make is to assume that anyone can be a mentor. WRONG! This mentality often is the same mentality that causes systems to move good technical staff into management positions and then wonder why the new manager is
One of the big mistakes systems make is to assume that anyone can be a mentor. WRONG! This mentality often is the same mentality that causes systems to move good technical staff into management positions and then wonder why the new manager is
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
failing. Technical knowledge does not presume possessing the knowledge and skills to be an effective mentor.
Mentoring has its own fundamental knowledge base, its own set of skills, and its own set of indicators of success. Many systems feel that a part of a supervisor’s role is to mentor those they supervise -
Mentoring has its own fundamental knowledge base, its own set of skills, and its own set of indicators of success. Many systems feel that a part of a supervisor’s role is to mentor those they supervise -
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
nd in some rare cases this can be effective - but too often the role of supervising conflicts with the role of mentoring.
Think about this… the role of a mentor is to understand a prot?g?s strengths and limitations and to create a relationship based on trust. This trust means the prot?g? feels confident they can t
Think about this… the role of a mentor is to understand a prot?g?s strengths and limitations and to create a relationship based on trust. This trust means the prot?g? feels confident they can t
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
alk with their mentor about what they are not doing well in their job and what they have actually done wrong without performance repercussions.
Wow, it would take a very special mentor/supervisor who could listen to what a prot?g? is telling them they are doing wrong, to be able to balance their two roles, and not
Wow, it would take a very special mentor/supervisor who could listen to what a prot?g? is telling them they are doing wrong, to be able to balance their two roles, and not
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
lip into the typical supervisor performance monitoring role. In some work cultures, a supervisor’s role is defined as a micro-manager who is to look for errors in their supervisee’s performance and provide consequences for these errors. In this type of work environment the combining of the roles of supervisor and
ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
mentor will not work.
No employee/prot?g? will learn to trust a supervisor/mentor who is expected to document everything they see an employee do that does not meet expectations. This type of work environment may say they are mentoring employees but they actually are showing their ignorance about mentoring.
So how
No employee/prot?g? will learn to trust a supervisor/mentor who is expected to document everything they see an employee do that does not meet expectations. This type of work environment may say they are mentoring employees but they actually are showing their ignorance about mentoring.
So how
easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
does an agency balance the need for leadership in training employees and supervising and monitoring for quality? Good question and there is an answer. The role of mentor is not a part of the supervisor’s role. Mentors are selected because they have the needed knowledge and skills to pass on to others, they are goo
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
teachers or guides, and they do not have supervisory responsibilities for their prot?g?s. Mentors then are selected on the basis of their expertise and knowledge of specific content, their facility in applying the content, and their mentoring skills.
So what this is actually saying is - if an agency wants to prov
So what this is actually saying is - if an agency wants to prov
and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
ide quality mentoring which results in quality services and products - they must set up a mentoring system. The components of this system include:
· defining a mentor application process
· defining mentor competencies
<
· defining a mentor application process
· defining mentor competencies
<
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
--[if !supportLists]-->· defining outcomes of mentor process
· defining an application process to identify potential mentor candidates
· selecting from mentor applicants those that meet specific cri
· defining an application process to identify potential mentor candidates
· selecting from mentor applicants those that meet specific cri
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
teria to become a mentor candidate
· training mentor candidates in specific mentoring knowledge and skills
· supporting mentor candidates as they move through the mentor training process, and
·
· training mentor candidates in specific mentoring knowledge and skills
· supporting mentor candidates as they move through the mentor training process, and
·
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
credentialing those candidates that meet mentor competencies.
In order to ascertain whether a mentor candidate receives the mentor credential requires the system to
· provide direct training and technical assistance to the mentor candidate during
In order to ascertain whether a mentor candidate receives the mentor credential requires the system to
· provide direct training and technical assistance to the mentor candidate during
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
heir candidate phase
· provide opportunities for the mentor candidates to observe and experience mentoring being provided by a credentialed mentor
· co-mentoring with a credentialed mentor and
·
· provide opportunities for the mentor candidates to observe and experience mentoring being provided by a credentialed mentor
· co-mentoring with a credentialed mentor and
·
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
being observed by a credentialed mentor while providing mentoring
So becoming a mentor requires that mentor candidates exhibit competence in understanding what mentoring is about and exhibiting the skills that results in competent performance by the prot?g?.
Competent mentor and prot?g?
So becoming a mentor requires that mentor candidates exhibit competence in understanding what mentoring is about and exhibiting the skills that results in competent performance by the prot?g?.
Competent mentor and prot?g?
t?
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
erformance is always assessed by whether the delivery of improved or quality services and products.
Steps of Mentoring Process
1. Application – An application process and procedures are defined
2. Selection – qualified personnel review appli
Steps of Mentoring Process
1. Application – An application process and procedures are defined
2. Selection – qualified personnel review appli
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
cations and select mentor candidates
3. Content Training & Technical Assistance
· Adult Learning
· Levels of Learning
· Problem Solving
· Strategic Planning
4. Structured Observation – Watch an accomplished mentor work with a prot?g? using a process to observe key elements
3. Content Training & Technical Assistance
· Adult Learning
· Levels of Learning
· Problem Solving
· Strategic Planning
4. Structured Observation – Watch an accomplished mentor work with a prot?g? using a process to observe key elements
.
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
ong>5. Co-Mentoring – Plan and conduct a co-mentoring session with an accomplished mentor
6. Independent Mentoring – Conduct a mentoring session with an accomplished mentor observing
7. Initial Credential
6. Independent Mentoring – Conduct a mentoring session with an accomplished mentor observing
7. Initial Credential
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
ng> – When all competencies are achieved become a mentor to prot?g?s
In summary, establishing a mentor system in your agency is a multi-phase process that results in the mentor candidates evidencing expertise in specific content and the ability to coordinate and facilitate smooth outcomes-based mentoring session(s)
In summary, establishing a mentor system in your agency is a multi-phase process that results in the mentor candidates evidencing expertise in specific content and the ability to coordinate and facilitate smooth outcomes-based mentoring session(s)
tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products
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