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Main Subject - Who Is Managing Your Career?
I was reminded of this story by Trish, a former colleague. I hadn’t forgotten, because it was the catalyst for a new career advancement strategy I developed. In my various human resource roles I always advise my clients to consider a rang
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
e of self promotion strategies to advance their career. As a result of the case study below, I developed a new strategy to take the initiative to keep their own company employee file updated by ensuring the Human Resource Department recei
; 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
ved and recorded in their employee file a pr?cis of any new skills, qualifications or experience they had gained. This is important if they don’t want to be overlooked for promotion, considered for special projects, receive appropriate re
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
muneration, receive a good and accurate reference, and as we will see in this “real" case study, to keep a job.
Case study
Jill completed a degree over an 8 year period. She graduated with a double major in commerce and information tech
Case study
Jill completed a degree over an 8 year period. She graduated with a double major in commerce and information tech
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
nology. However, she is a very private person and no one in her company knew she was studying. After graduation Jill stayed in the same job where her skills were not utilised, although she did apply for some jobs outside her company
Amal
Amal
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
gamation and a new service direction for the company had been mooted for a year, and retrenchments seemed inevitable. Jill thought she would be retained; in fact she seemed confident and would never discuss it. Then one day the bad news c
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
ame. She was being retrenched.
The decision was made by looking at the application forms and other data in the employees’ files, such as professional development courses attended, higher duties performed and attendance records, for insta
The decision was made by looking at the application forms and other data in the employees’ files, such as professional development courses attended, higher duties performed and attendance records, for insta
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
nce. Further, Supervisors were consulted and employees were rated against new criteria. Jill was deemed to be amongst the least qualified to fit in with new organisation structure and to work with the new computer system. Trish and I ques
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
tioned Jill about this unfair process. Surely appeals should be heard. We were outraged, saying “they can’t do that". But after questioning Jill further, several damming facts emerged.
When Jill told her supervisor about her qualificatio
When Jill told her supervisor about her qualificatio
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
ns the supervisor was very surprised. She reminded Jill that employee files were discussed at meetings, and employees were given the opportunity to update them. Not only did Jill miss this meeting, a memo had come around reminding employe
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
s that updating their employee file was in their best interest and Jill took no action. Now arbitrary decisions had been made and there were no appeals.
We agreed with her supervisor’s opinion that she had been given every opportunity to
We agreed with her supervisor’s opinion that she had been given every opportunity to
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
secure her place in the new system, but made absolutely no effort to promote herself and demonstrate that she could make a positive contribution to the “new order", as it were.
Incidentally, we asked about performance appraisals, and ap
Incidentally, we asked about performance appraisals, and ap
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
parently the company didn't conduct them.
Soon after this event I undertook research amongst my contacts in Human Resource Management and discovered that although most HRM’s kept employee files updated when their employees undertook trai
Soon after this event I undertook research amongst my contacts in Human Resource Management and discovered that although most HRM’s kept employee files updated when their employees undertook trai
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
ning and development provided by the company, they hadn’t given any thought the advantages an employee would gain by self promotion by keeping their own file updated.
Human Resource Managers in smaller companies did not think it was impo
Human Resource Managers in smaller companies did not think it was impo
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
rtant. However HR Managers in larger companies, thought this was a good idea as the powers above occasionally called for an audit on current employees’ skills and experience and also wanted statistics from performance appraisals, based on
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
certain criterion.
Most of my contacts agreed that it would be useful to have a comprehensive employment file when asked for references or particulars on past employees. A couple of people thought that many former employees had lied abo
Most of my contacts agreed that it would be useful to have a comprehensive employment file when asked for references or particulars on past employees. A couple of people thought that many former employees had lied abo
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
ut qualifications, skills or experience, that didn’t correlate with their job description and other data in their files.
Surprisingly, 50% of the personnel from larger companies confirmed that employment files were often used when employ
Surprisingly, 50% of the personnel from larger companies confirmed that employment files were often used when employ
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ees were being considered for a salary increase and before they would be considered for a promotion.
Jill may have had a future in the new company structure if she had been proactive and ensured her employee file was regularly updated to
Jill may have had a future in the new company structure if she had been proactive and ensured her employee file was regularly updated to
.
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
reflect her qualifications, professional development or any achievements, in and outside work that were relevant to her employment status.
Although the company could have practiced better human resource management by conducting regular
Although the company could have practiced better human resource management by conducting regular
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
performance appraisals, which may have uncovered Jill’s degree and other relevant information, ultimately she was solely responsible for her retrenchment by not proactively managing her career and leaving it to others to decide her future
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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