Navigating the Regulatory Maze to Enable Trial Continuity with Digital Solutions

Strategies to mitigate risk, ensure regulatory compliance and build a case for the future

The scale of the challenges those of us responsible for clinical development faced and continue to deal with during the COVID-19 pandemic has been unprecedented and complex. Across our industry, everyone responsible for the conduct of clinical trials has been forced to make sound decisions, fast. Digital solutions have seen wider acceptance to maintain clinical trial continuity. While traditionally, there has been slow uptake for these technology-based solutions in clinical trials, primarily due to a lack of legal, including patient and data privacy, and regulatory frameworks, stakeholders have recognized their key suitability for supporting clinical trial continuity during the pandemic.

In recent guidance documents, many regulatory authorities have acknowledged or advocated the use of telemedicine and a range of technology solutions when necessary to support clinical trials during the COVID-19 outbreak. However, guidance from regulatory authorities varies across countries and jurisdictions, and is continuously being updated, with some authorities providing more direction than others. In this webinar, regulatory affairs experts will discuss common themes of current regulatory authority guidelines and important considerations to enable you to successfully navigate the regulatory landscape when planning to introduce digital solutions to clinical trials.

To date, regulatory authorities have repeatedly advised that emergency measures being facilitated during the pandemic are only interim measures, and that things will essentially revert to business as usual once COVID-19 is under control. However, industry experts recognize the circumstances of the COVID-19 pandemic create important opportunities to change and improve the way clinical trials can be run going forward. We will discuss how digital solutions, including decentralized trials, can improve the trial experience for patients, maintain regulatory compliance, increase efficiency and speed delivery of reliable data. Finally, we will discuss how successful demonstration of adoption of a digital framework that safeguards patient safety and produces accurate and reliable data during the pandemic will help fuel the needed agency buy-in to progress this promising approach beyond the pandemic.

Speakers

Christina Cocciardo, Director, Regulatory Affairs, PPD

Christina Cocciardo is director of development solutions within regulatory affairs at PPD. She has more than 27 years of CRO and pharmaceutical industry experience as a regulatory leader with expertise in strategy development for global markets. She provides project-specific regulatory affairs strategy counsel, technical expertise and coordination oversight for key client projects. Cocciardo collaborates extensively with clients, regulatory consultants and regulatory authorities to provide exquisite quality control for the submission of documents. For the past several months, she has been extensively involved in COVID-19 clinical studies and has practical, real-world insights and experience to share on this topic.

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Marci Aderiye, Director, Regulatory Affairs, PPD

Marci Aderiye, MS, RAC, is global director of regulatory affairs at PPD with more than 30 years of experience in regulatory affairs and quality assurance, as well as both clinical and preclinical research management experience. She serves as a company representative to the FDA and other regulatory authorities and provides strategic project management and regulatory consulting for Phase I-III clinical and observational trials for pharmaceutical, biotechnology and vaccine sponsors. Her experience includes responsibility for regulatory submissions for tuberculosis vaccine pipeline products in Africa and the US. Currently, Aderiye focuses on work with government and industry sponsors to expedite submissions to FDA for COVID-19 therapies and vaccines.

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Ilse-Maria Nolan, Senior Director, Regulatory Affairs, PPD

Ilse-Maria Nolan is the senior director of global regulatory affairs at PPD, responsible for leading PPD’s regulatory intelligence, policy & advocacy team. An industrial microbiologist and pharmacologist by training, Nolan has 20 years of clinical development industry experience, including positions of increasing responsibility within regulatory affairs and quality assurance groups at leading clinical research organizations and a top-50 biopharmaceutical company. Through this experience, she has developed a strong track record of success in leadership, driving change and policy formulation. She is an advocate for regulatory affairs and plays an active role in industry associations, participating both as a steering committee and editorial board member. She currently serves as a member of PPD’s COVID-19 regulatory affairs landscape committee.

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