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Headache #1: An employer shipped out copies of an expensive video program to dozens of distant managers without providing HR staff to either answer questions or ensure that employees were actually following and learning from the programs. Many of the managers turned on the videos in break rooms and left them running while employees came and went.

Headache #2: During face-to-face anti-harassment training given by a lower-level supervisor, he let it be known that he had no use for

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

the training and was just going through the motions.

Regardless of whether or not you comply with any mandated sexual harassment training laws, jurors are increasingly unwilling to accept a "check the box" approach to harassment prevention training; they want to see training that is interactive, memorable, supported by senior management, and delivered by a credible, well-trained presenter. Given that an ineffective training program will provide little or no protection in the even

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

Examples of combination products may in

t of a lawsuit, let's take a look at the essential components of an effective training program and identify some of the most common pitfalls.

Effort May Count - But Not Much

Harassment prevention is not an easy subject to teach. One reason many training programs are of such poor quality is that a real mastery of the subject requires a high level of legal understanding coupled with the practical concepts understood by those who have a firm grasp of the day-to-day realities of the

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

workplace. Many training programs fail to integrate the two disciplines and thus fall short in one respect or the other.

Another major reason is that, up until now, most employers have viewed anti-harassment training as something you show up and provide information about, then let them "learn" by doing. Employers, however, cannot afford to let supervisors “wing it” when it comes to learning how to recognize, refrain from, or properly handle sexual harassment. Supervisors and manag

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

ers not only have to master complicated concepts in advance, but must also practice proper techniques for effective prevention and complaint handling. That requires time, attention, and education, not just training.

Who Should Train

As the quality of compliance training has increasingly become grist for the plaintiff attorney’s mill, the selection of an outstanding training provider a critical business issue. The advantages of in-house HR or training personnel include cost and th

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

Combination pro

e fact that such staff is knowledgeable about the particular workplace, the employees being trained, and the particular business or industry.

On the other hand, harassment prevention is a topic in which knowledge is necessary but not sufficient as some of the most challenging components for instructors is anticipating and responding to the challenging questions and negative attitudes of course attendees. Additionally, because of the natural resistance many employees and managers i

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

itially feel towards this subject matter, they are more likely to question the “agendas” of in-house trainers, no matter how neutral or objective they may strive to be.

Harassment prevention training specialists – whether internal or external - should be able to offer: legally accurate and up-to-date analysis as well as practical and realistic programming; lively, interactive presentations; appropriate educational techniques; and a variety of formats, follow-up and curriculum optio

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

ns. One thing is clear; educational research indicates that adult learners learn better with a live teacher - especially one they can respect.

Training Mistakes: When the Treatment is as Bad as the Disease

Mishandled training not only may fail to insulate an employer from harassment claims and punitive damages awards, but also can create its own legal problems. Accordingly, employers should seek to create training sessions that are "jury worthy" in tone and language by avoiding

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

the following traps:

Asks the learner to make legal conclusions: Some harassment prevention training programs present scenarios and then ask the participant "Is this harassment?" The learning points that such a question is trying to cover can be communicated just as effectively without making a legal conclusion. In addition, questions that ask for legal conclusions are problematic in that they can be used as evidence against the company in the event of a future lawsuit if a manag

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

r or employee engages in behavior that was defined as "harassment" in a previous training class. Essentially, the company's hands may be tied because of evidence it created against itself. See Cadena v. Pacesetter Corp., 224 F.3d 1203 (10thCir. 2000).

Increases Liability by "Setting the Bar Too High": For example, in workplace harassment training, a program may state that any discussion of personal relationships in the workplace is inappropriate. While this approach is well-inten

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

ded, it can actually be damaging to the organization for the following reasons: 1) If the program "concludes" that such behavior is unacceptable, then it has made a legal conclusion that could be used against the organization in the event of a future lawsuit, and 2) An overly "sanitized" message may also spark an unwillingness on behalf of the learner to take the content in the program seriously.

Focuses only on sexual harassment: The US Supreme Court and the EEOC have made clear

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

Following aspects would a

that a harassment prevention program should address all of the "protected categories." See Equal Employment Opportunity Commission, Enforcement Guidance: Vicarious Employer Liability for Unlawful Harassment by Supervisors (6/18/99); See also Burlington Indus., Inc. v. Ellerth, 188 S. Ct. 2257 (1998) and Faragher v. City of Boca Raton, 118 S. Ct. 2275 (1998). To be effective, a workplace harassment prevention training program should address harassment related to gender, race, nationa

dd to the challenges in developing combination products:

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

origin, color, disability, age and religion as well as other "protected categories" under state law, such as sexual orientation.

Fails to Provide Appropriate Content for Appropriate Groups: One of the greatest challenges in creating an employment law training program is ensuring that the content communicates the correct information, while not encouraging employees to bring lawsuits. Employees primarily require information about the employers' commitment to a harassment-free work

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

place, assurances against retaliation as well as instruction on the employers' policies and procedures, and expected standards of conduct. Managers need education not only in recognizing harassment and discrimination and refraining from it, but also in proper handling of complaints or other situations possibly raising the issue, as well as such matters as preventing retaliation and effective follow-up with the complainant. A thorough discussion of legal liability is really only ap

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

propriate for managers, who need to know more detailed information about the law, and the specific risks that misconduct poses to both them and the company.

Focuses narrowly on legalese: Harassment/discrimination prevention programs are designed to educate employees and managers - not lawyers or HR experts. Therefore, when discussing "the law," employers should focus on what employees most need to know: what is and isn't harassment, how to report it and how to maintain a retaliatio

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

-free workplace. Manager training programs must give managers and supervisors the practical tools they need to implement a policy successfully, how to legally interview for hiring and promotion, and how to manage performance in a way that does not discriminate against anyone on the basis of protected characteristics.

Fails to Reflect Your Organization's Specific Workplace Policies: A harassment/discrimination prevention program should routinely incorporate an organization's specifi

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

Professional from academic institutions, pharmaceutical industries, health care indust

c workplace policies. In fact, if a training program includes a tracking mechanism that shows receipt and acknowledgement of that policy, then the program performs the dual function of training and policy dissemination. In addition, training should include policy-related issues such as reporting procedures, confidentiality issues, the conduct of investigations and retaliation prohibitions. While employer policies should emphasize zero tolerance with respect to discrimination and ha

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

rassment, they also must encourage employees to report inappropriate behavior-with many options in which to report a complaint, including the option of reporting a complaint to a person not in the employee's chain of command-to ensure confidential and prompt investigations and to protect victims and witnesses from retaliation.

Fails to Replicate a Realistic Working Environment: Many harassment prevention programs use vignettes and case studies that seem unrealistic and "hokey" and

.

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

on't represent the more common types of situation that employees encounter in the workplace. This approach not only causes chuckles from employees, a jury you're trying to convince of your good-faith efforts to prevent a serious topic will likely have the same reaction.

The Bottom Line

HR should be defined not by what it does, but what it delivers. A sound understanding of the civil rights laws is just a starting point in the quest for legal compliance and effective work relation

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

Companies that provide selfless information through particip

s; it's the rest of the journey - the attitude and expertise of the trainer, the quality of the content, the receptivity of the learners - that determine how successful the harassment/discrimination prevention program is in meeting its goals. The savvy HR professional will pick a harassment prevention training provider who has the emotional intelligence as well as the expertise and experience to transform a skeptical audience into compliance partners and more effective communicators

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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