New ways clinical trials and real-world studies will be conducted…
Professional Regulations experts who work in collaboration with the Commercial and Medical Teams in order to deliver compliant materials to the markets and externally
Disclaimer: Please note that the speaker’s interview is based on their own experience and view and does not engage the one of Takeda under any circumstances.
What are the best current practices that can simplify and improve the processes in International Advertising and Promotions?
Nowadays, Ad Promo professionals are increasingly viewed as business partners in pharmaceutical organisations, working with commercial teams in order to deliver best-in-class materials that comply with Global Laws, Regulations and Guidelines.
On top of sharing regulatory advice and guidance, working towards enhancing the contents’ creation by clearly understanding the Business deliverables is highly helpful. Being savvy and strongly knowledgeable about drugs and clinical studies that are the basis of the materials, while acting as experts in terms of regulations and procedures to protect the business from complaints and legal procedures, will dramatically impact positively the company in terms of performance, time, cost-savings and reputation.
How could Ad Promo professionals benefit from an improved data strategy?
As healthcare becomes increasingly tailored to the patient, corresponding ad promo materials must follow suit. Regulatory requirements prevent a high degree of customization within these materials and ad promo personnel can help to ensure that patients and HCPS are ethically educated about new and existing conditions and treatments. In an era of targeted promotional delivery, it remains imperative that teams create safeguards around patient privacy while sharing and ensuring unbiased information.
Given EU policy is dependant on local regulations as well, is there a way to ensure a more standardised Ad Promo landscape regarding rules and regulations?
In the Pharmaceutical Industry, we partner with IFPMA and EFPIA, in order to deliver compliant materials to Healthcare Professionals that help in the disease management of our end-users: Patients. Those association and body are already doing a great job in communicating and helping the industry with standards of rules and regulations at the European Level that are harmonised. With that in mind and given that guidelines, laws and regulations are also specific to each local country, there is a clear legal demand in the industry policies to incorporate the requirements of both in order to deliver compliant materials externally.
Caroline Petit is an International Advertising and Promotions Lead, Associate Director, Global Regulatory Affairs at Takeda, RAC EU/ US and CCB US Compliance Board certified. Caroline has worked for more than 15 years in the pharmaceutical industry and have been trained in the field of EU& US Law and Regulations, Cognitive Neurosciences, Digital Transformation, Pharmaceutical Medicine, Business and Marketing, both in European and US Top-Tier Universities. She has a significant experience in Global Advertising and Promotions, focusing on therapeutic areas such as Rare Disease, Neurosciences, and LSD.
Her passion and strong commitment to help patients live a better life has driven her journey throughout pharmaceuticals.
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