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We obtain strategic results by aligning HR mission, vision and values. The following overview highlights a macro approach to project management. Seeking a stretch assignment, such as ownersh

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

ip of a major corporate HR initiative, we lead our organization by example. Strategic project management affords an exciting and challenging opportunity to direct our futures and show case ou

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

talents.

The VP of HR announces to the team that we must transition from a decentralized function to a centralized function within six months placing you in charge. The set timeframe requir

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

ed to realize budget improvement for immediate bottom line results. The cost savings will be unprecedented for the dozens of locations countrywide. Senior management set the expectation, on

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

ime – on budget, ensuring precise project implementation.

You take pride in your ability as an accomplished HR generalist to deliver results and get projects done. Success comes, in part, fr

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

om your tactical / transactional ability to prioritize assignments and communicate the necessary timeline to managers.

By the execution of project leadership skills, you will add measurable s

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

rategic value to your organization and your own skill-set. A project assignment budgeted in the five, six or seven-figure range will require skills and HR competencies including:

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

ommunications

documentation

execution and accountability

formal controls

Strategic HR leadership necessitates project management skills that require you see the big pict

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

re. Your approach may be similar to the strategic creation of your HR mission, vision and values. Likewise, the values of a project assignment become the blueprint upon which you make projec

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

t planning decisions.

HR Influence

Your scope of influence requires proficient skills in project plan and design. This may include a draft plan to senior management detailing how you will a

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

complish this task. In addition, you may be required to design assessment tools where they may not exist, or evaluate and communicate risk up line to your organization. Measurements includin

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

corporate resources, budget assumptions, timeline and accountability are typically established. These metrics develop into key result areas as they relate to time, cost and objective.

Your

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

span of influence will require you to work effectively across department lines. You may be asked to understand and effectively operate with “politics” and “organizational constraints” from pr

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

ject start to completion. How well you manage these variables will determine your project success.

Your ability to influence and lead the project assignment may grow in stages. The personal

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

ity type you display, cool and confident or nervous and frazzled, will set the project tone. Your mentoring and motivating team members will determine how this project approaches its potentia

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

. Rapport building will lead to trust, ultimately enabling a broad reach and results across department lines as needed.

Your HR project influence then goes beyond mentoring to enable empower

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

ment of team members to accomplish their mission. Corporations without a team-based environment may experience more “forming and storming” before getting the project off the ground. Sponsori

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

g senior management demonstrates its vision by the appropriate modeling of leadership. This then becomes a subset of project delegation. False starts and difficulty meeting preliminary deadl

.

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

ines may indicate early lack of alignment.

While complex, often intimidating and frequently overwhelming in the earliest stages, HR professionals who build a step-by-step plan in collaboratio

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

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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