This International Women’s Day, Xtalks is celebrating the incredible women who have presented in our webinars in the past year. From March 2017 to March 2018, Xtalks has been proud to host nearly 40 webinars led entirely by a panel of female speakers, with 19 of them featuring two or more women who are experts in their field.
In reflecting on these events featuring female speakers from the life science, pharmaceutical, medical device and food industries, here are five women-led, educational webinars that can keep you informed this International Women’s Day and beyond. Follow the links to watch these free, on-demand webinars now.
1. Combination Product Regulatory Requirement Complexities and the Impact of the 21st Century Cures Act
Diane Beatty, PhD, Managing Director, Regulatory Affairs and Product Development, Cardinal Health Regulatory Sciences
Jean Dehdashti, MSc, RAC, Scientist III, Regulatory Affairs & Product Development, Cardinal Health Regulatory Sciences
In this webinar, the speakers discussed regulatory requirements for medical devices which are paired with drugs or biologics, known as combination products. Since the FDA’s approval pathway for these combination devices can be tricky to navigate, the speakers sought to provide some much-needed clarity to those watching the webinar. Both Dr. Beatty and Jean provide regulatory consulting services and they have a combined 42 years of experience in the development of pharmaceuticals, devices and combination products.
Professor Christine Jenkins, Scientific Leader, George Clinical
Dr. Marisa Petersen, CEO, George Clinical
Chronic obstructive pulmonary disease (COPD) will be the third leading cause of death globally by the year 2030, according to statistics from the World Health Organization (WHO). Since air pollution and other health factors are making this disease especially prevalent in the ever-growing Asia-Pacific region, speakers in this webinar explored the future of respiratory trials in those countries. As a specialist in thoracic medicine and a leader of multiple clinical trials of reparatory diseases, Christine was well-positioned to speak in this webinar. Dr. Petersen offered a pharmacist’s perspective of respiratory trials in the emerging region.
Sam Sather, Quality and Regulatory, TrialConsent, CRF Health
Giga Smith, Director of Research, Coastal Carolina Health Care
In this event, the speakers discussed electronic informed consent (eConsent), where patient consent to participate in a clinical trial is collected in a digital format as opposed to the traditional paper copy. The speakers presented survey results from sites to determine the extent to which eConsent tools were being used. With Sam’s focus on promoting quality systems within clinical research institutions, and Giga’s experience as a director of clinical research programs at sites, this event helped others in the clinical trials industry decide how to best implement eConsent technology.
Nikki Fink, Director of Patient Access and Retention Services, PRA Health Sciences
Kate Hersov, MD, Founder, Jumo Health
Enrolling enough of the right patients in any clinical trial is a challenge, but patient enrollment and retention in studies involving children can be even more complex. In this webinar, Nikki used her 17 years of recruitment experience to help others in the pediatric clinical trials industry solve their participant enrollment challenges. Dr. Hersov brought her unique perspective as founder of a medical education company for children to the discussion.
5. Drug Name Development: The Regulatory Changes to Know About & How to Prepare for a Successful 2018
Brittany Scott, Creative Director, Addison Whitney
Betsy Lard, VP, Managing Director, Addison Whitney
Barbara Gerber, VP Managing Director – London, Addison Whitney
Nancy Kirschbaum, Senior Director, Regulatory Strategy and Consulting, Addison Whitney
The FDA, EMA and Health Canada have all made changes to their biologics and biosimilars naming guidelines in the past few years, which can have a major impact on the regulatory approval pathway. Brittany, Betsy, Barbara and Nancy discussed the requirements put forth by these three regulators and used their experience to make recommendations on how drug developers can be in compliance.
Xtalks is now preparing for the next phase of women-led webinars with nine out of 22 of our upcoming events featuring female speakers. With more women becoming authorities in their respective fields and sharing their expertise by speaking in webinars and at conferences, increasing gender parity in these highly-regulated industries will help companies face future challenges with confidence. Register for our upcoming webinars to stay on top of the latest in your industry.