The pharmaceutical industry is inarguably the most heavily regulated sector of the economy. Penalties are often imposed on many organizations in this sector for violation of applicable rules and statutes. The Food and Drug Administration (FDA) has issued 691 Form 483s to drug makers in the year October 2015-September 2016.1 Companies may face huge penalties, and in certain extreme cases, may have their license to operate annulled, if they don’t comply with the norms specified by drug-regulatory authorities.
How can drug manufacturers make sure that they comply with applicable norms? Among the various aspects they need to consider, delivering effective training to their staff on prescribed norms is the most important. Most pharmaceutical companies are using the self-paced online learning format to impart compliance training to their personnel. Today, we will see how e-learning helps deliver regulatory affairs training of high quality to the staff of drug manufacturing organizations.
You can use the online learning medium to impart training on the following regulatory aspects.
- Good Manufacturing Practices (GMPs)
- Document controls and maintenance of records
- Laws pertaining to trials on human and animal test subjects
- Regulations pertaining to safety
- Intellectual property rights (IPRs)
- Anti-graft rules
- Prevention of off-label marketing of drugs
Good Manufacturing Practices (GMPs)
Technology-enabled learning modules are very useful tools to complement classroom sessions on GMPs. Online learning nuggets are ideal to explain the production norms, prescribed by the FDA and other organizations such as the World Health Organization (WHO), in an effective manner. One of our clients in the bio-pharmaceuticals space uses bite-sized online learning modules to train its staff on GMPs with a high degree of efficacy.
Document controls and maintenance of records
Scenario-based online learning resources can be used to provide easy and clear understanding of the guidelines pertaining to electronic records and electronic signatures (ERES) stated by 21 CFR Part 11 of the Code of Federal Regulations. Simulations can be used to effectively impart high quality training on the prescribed procedures of handling documents and maintenance of signatures, in the electronic format.
Laws pertaining to trials on human and animal test subjects
Self-paced e-learning courses are ideal complements to traditional workshops in educating the staff of pharmaceutical companies on conducting drug trials on animal and humans. Online learning materials containing case studies are very useful to explain the consequences of non-compliance. Today, thanks to developments in technology such as virtual reality (VR), it is possible to create ‘virtual laboratories,’ which facilitate practice on different lab procedures. This helps acquire expertise over the methods of drug experimentation.
Regulations pertaining to safety
E-learning can be used for training the workforce of pharmaceutical companies on rules pertaining to industrial safety, very effectively. Scenario-based online courses are very useful in helping learners understand the dangers of violating safety norms. You can also use videos to educate staff on various safety procedures. For example, one of our clients that manufactures vaccines used video-based learning modules to demonstrate the precautions to be taken while working with live viruses.
Intellectual property rights (IPRs)
Web-based learning modules can be used to impart good training on preventing the violation of patents and other intellectual property rights. Online learning resources containing case studies go a long way in making personnel aware of the consequences of violating these rights. It is a good idea to create online checklists that staff can refer when they have doubts whether their actions constitute a breach of IPRs.
Drug manufacturing organizations, which resort to illegal means to boost their sales revenues such as bribing doctors to prescribe their products, can face serious consequences, including hefty fines and imprisonment of their executives. You can use online courses to educate your staff about the consequences of violating anti-bribery laws. E-learning modules containing case studies are very useful to explain the implications of offering kickbacks to physicians.
Prevention of off-label marketing of drugs
Off-label marketing is the practice of promoting a drug for curing ailments other than what it is intended for. This practice is prohibited by law and can attract serious penalties. Technology-enabled learning resources containing scenarios can be used for educating the sales personnel of drug manufacturing companies on the laws pertaining to off-label marketing of medicines. You can also provide your medical reps mobile-compatible microlearning modules that list the conditions which a specific drug can treat. The reps can refer to these learning resources during interactions with doctors.
Compliance training of high quality goes a long way in enabling manufacturers of medicines ensure adherence to prescribed norms. How do you use the online learning format to impart training on regulatory affairs? We’d love to know.