Over the past five years, the cosmetic industry has met with several legislative changes. Within the new legislative package, including the new REACH and CLP, it is important to find a comfortable routine that will minimize costs while staying effective and compliant with all regulations.
Interview with Gian Luca Trinei
Read the interview with Gian Luca Trinei, Chief Compliance Officer Italy, Pfizer.
The stringency of anti-corruption and anti-bribery laws in Europe is starting to resemble or even surpass that of US legislation. What measures is the pharmaceutical industry taking to compensate for the growing number of regulations and initiatives?
The pharmaceutical industry is reacting to the growing number of initiatives through the implementation of Compliance programs which take into consideration – where possible – the multiple anticorruption and/or transparency regulations which are in place in a specific region/country.
A good example is represented by the synergy that exists while producing the FCPA trend analysis and the EFPIA transparency disclosure for several kinds of transactions undertaken with Governmental Officials or Health Care Professionals.
A similar synergy is exploited when a company has to comply with different anti-corruption laws. In our case, we have to respect both FCPA prescriptions while dealing with Governmental Officials and at the same time with local Legislative Decree 231/2001 whose (main) objective is to prevent corruption in the Public Administration.
Although the operational ways in which the two laws pursue a similar objective are quite different, it is possible to review a specific process form both points of view, exploiting controls that could satisfy the need to prevent corruption.
Pharma's reputation continues to suffer, and trust is not just something the industry communicates – it has to be earned through industry action. How do you think the industry could maintain or improve trust?
There are several actions that the Pharmaceutical industry could take to earn better trust from the society where it lives:
· Being transparent and ethical in everyday behavior;
· Being focused and inspired by the patient’s need;
· Considering the needs of all its stakeholders, particularly those of the payers in countries where the health care system has to provide assistance to patients while respecting an increasingly restricted expense budget;
· Engaging in initiatives that could improve life for all citizens and patients; respecting and exceeding the prescription of Environment, Health & Safety laws in the production plant;
All of the above behaviors might help the industry in being perceived not as a group of companies only focused on profits, but as a member of the society where they live who has a great sense of solidarity with the surrounding environment.
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This training will focus on occurrence of particles in drug products, effects of protein aggregates, critical process and parameters. Attendees will gain overview of on utility and limits of predictive experiments, learn concerns from the authorities and relevant aggregation guidelines, and more.
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This two-day conference will serve as a platform for an open and dynamic dialogue with HCPs and patients to achieve common goals. Learn how to embed compliance in the business and develop one simple system for managing compliance & transparency in a complex and regulated environment.
Dr. Asma Ibrahim Al Mannaei, Director, Healthcare Quality Division | HAAD
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