How Do Medical Affairs and Regulatory Affairs Professionals Co-Create The Regulatory Strategy From The Beginning?
New ways clinical trials and real-world studies will be conducted…
Promote digitalisation efforts that are made in a consistent and collaborative way
What potential does digital transformation hold for regulatory affairs professionals?
Today, regulatory affairs, especially regulatory operations, is a knowledge work heavy discipline that significantly depends on manual work with data and information to prepare various types of health authority submissions. EMA’s digital transformation puts the focus on “data first” submissions, thus aiming to create an end-to-end “data supply chain” that will greatly simplify the work and increase the speed, the reliability and the transparency of the data. It will free up time for the regulatory affairs professional to focus on what matters the most: scientific dialogue and interaction with the national agency experts.
Where do you see the future of regulatory affairs by 2025?
2025 is just around the corner, so I hope that by then we will be well underway with this digital transformation. It’s good news because of the ever-increasing demand on companies and regulators to provide more data more quickly, to deal with new requirements. For example, supply chain information to support the management of shortages, but also more product details for better pharmacovigilance and quicker response to issues like nitrosamines and titanium dioxide. There is an abundance of Type IA variations to be replaced by data-only submissions which has to potential to eliminate massive amounts of paperwork.
What are the biggest challenges in adapting current strategies to meet new regulations?
As multinational companies, we are doing business globally. So my only hope is that these digitalisation efforts are made in a consistent and collaborative way, that EU member states will be working with the EMA and the US around common international data standards and cloud platforms to prevent the creation of multiple incompatible systems. As industry we should continue to advocate for this and insist on having a seat at the table to co-create this future.
Patrick Middag, M.Sc., MBA, is an Associate Director, IT Business Partner Global Regulatory Sciences EU & Canada and IDMP at Bristol-Myers Squibb. He leads the European alignment of global Regulatory IT initiatives at Bristol-Myers Squibb and is the company’s IDMP program IT lead. Patrick started at BMS in global labelling systems implementation, at that time focusing on PIM and Translation Management. He maintains external focus as a vice-chair of EFPIA’s ERAO and as an active member of the SPOR Task Force including the PMS-subgroup.
Patrick started his career as an IT professional in 1995. For many years, he was a technical specialist and consultant in software architecture, contributing to the delivery of business solutions. Working for mid-size pharmaceutical companies since 2001, he has experience with Enterprise Architecture, business-IT strategy alignment, and process improvement. Patrick obtained an Executive MBA degree from the Vlerick Business School in 2007.