COMPLIANCE, LICENCE TO OPERATE

Commercial healthcare companies are used to working in a highly regulated environment.

In addition to the applicable laws and regulations, there are also additional agreements between the stakeholders on the desired ‘behaviour’, the so-called self-regulation written down in codes of conduct (CGR, GMH). No company can operate without a solid set of compliance policies and procedures.

WHAT WE DO

All kinds of collaborations between companies and healthcare professionals are useful and necessary and often form the basis for improvements in healthcare.

Innovations very often find their way to the medical practice in partnerships between various profit and non-profit partners. In this situation, a risk can arise that the interests of healthcare providers and commercial parties no longer align. The patient must be able to trust that the care offered is truly based on the current medical scientific knowledge. There should be no doubt about the motivations of healthcare providers.

That is why clear standards and transparency are important and should ensure that the activities of all parties are transparent and within the laws and regulations.

Only then the industry can be successful in a responsible manner, doctors can provide evidence-based healthcare and patients can trust that the treatment they receive is the best care at the right time.

Healthcare compliance is the expertise that deals with these rules.

What can LORIOT do for your organization?

ADVICE

No situation is exactly the same, which makes it sometimes difficult to interpret the rules. Based on my broad business experience, I advise organizations on how to achieve business objectives in a compliant way.

COMPLIANCE PROGRAM

I support the implementation and maintenance of internal procedures (SOPs) as part of the compliance program.

REVIEW

Promotional materials and (financial) relationships must be reviewed. I provide compliance reviews.

TRAINING

I provide in-house training on CGR Code or EFPIA Code or any other tailor-made compliance training.

TRANSPARANCY OF FINANCIAL RELATIONS

I can advise organizations on implementation of systems that capture and report financial relations in accordance with the transparency rules of the CGR or other (European) disclosure regulations.

MONITORING

As part of the compliance program I can perform the monitoring of internal procedures and processes, create improvement plans and organize relevant training courses.

NON-INTERVENTIONAL STUDIES

As project leader of the non WMO-plichtig (NIS) review framework, I have been one of the founders of the regulated review of non WMO-plichtig medical scientific studies set up by companies. I advise companies how to set up their studies in order to get a positive review.

SPARRING - SECOND OPINION

Sometimes the compliance officer or management seeks a second opinion of an experienced professional. Together we can develop a collaboration plan.

These services can be provided on a project or a more structural basis if your organization has (temporarily) no dedicated compliance officer.

WHO IS LORIOT

My name is Eveline Loriaux and I started my own consultancy LORIOT in 2014. It is my firm believe that the role of the compliance officer must be more one of a business partner than a police officer. In addition to contributing to the success of the individual company or organization, (healthcare) compliance contributes to the integrity and reputation of the pharmaceutical/med tech industry. This is my daily source of inspiration!

With a broad experience in this industry, I connect compliance with other disciplines within the company.

After studying Biology at the Free University in Amsterdam, I chose my first job as a sales rep in a pharmaceutical company. In the years that followed, I held various positions (CRA – national and international, clinical research director, head medical department, business unit director, general manager, communications & corporate affairs director, compliance officer) at various companies.

As a certified (INSEAD Fontainebleau & Seton Hall Law School) healthcare compliance specialist I have more than 15 years experience as a compliance officer working for companies and as compliance consultant for national and international commercial organizations, trade associations, government and self-regulatory bodies.

For several years now, I am a member of the Code Committee of the CGR.

CONTACT

NAME

Eveline M. Loriaux