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The Shifting Global Regulatory Landscape: Dealing with Regulatory Affairs in an Uncertain Environment

1.0 RAC Credits On-demand On-demand Member: $0 Nonmember: $20

The Shifting Global Regulatory Landscape: Dealing with Regulatory Affairs in an Uncertain Environment

Up until mid-March 2020, regulatory professionals were traveling globally, attending meetings with regulatory agencies, planning for FDA Advisory Committees and CHMP Oral Explanations and attending conferences. where regulators would turn up to offer their current thoughts on various aspects of drug development. Now we are all working virtually, wondering how society might change as a result of COVID-19. This webcast will not try to predict how the geopolitical world will change as a consequence of COVID-19, but will cover current hot topics and emerging challenges affecting regulatory affairs professionals globally. Questions to be discussed include:

  • How will we complete the pivotal clinical trials where recruitment has had to be halted and how will we obtain FDA and CHMP buy-in to the changes we have had to make to patient numbers, endpoints and data collected?
  • Does COVID-19 create opportunities for industry (and regulators) to think what was considered unthinkable just a few weeks ago?
  • How do we manage the inevitable complexity of our Supply Chain when some countries remain locked down?
  • How do regulators accept more ambiguity in their benefit regarding risk assessments?
  • Is this an opportunity for more flexibility with initial approvals and a greater reliance on Post Marketing Requirements/Commitments?

We may not have all the answers, but we hope to help you apply additional creative thinking as you navigate the uncertainty of the current regulatory environment.


Learning Level(s):

Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.


Learning Objectives

  • Have better insight into how interactions with regulatory agencies are likely to change as a consequence of COVID-19
  • Improve your understanding of how clinical trials will need to be conducted in this new environment
  • Increase your understanding of the need to build risk mitigation strategies around the clinical supply chain


Who Should Attend

  • Regulatory professionals charged with providing regulatory strategy
  • Regulatory professionals responsible for developing CMC strategies
  • Professionals involved in Clinical Strategy & Clinical Operations


Speakers

  • Joseph Lamendola, SVP & Principal, Regulatory Center of Excellence, YourEncore

Over a 30-year regulatory career, Joe has been responsible for 30+ approvals across 10+ therapeutic areas. With hundreds, if not thousands, of agency interactions under his belt, Joe provides clients with the insights, relationships, and credibility needed to bring drugs to patients quicker. Beyond drug development, Joe is an expert in strategic alliance governance and organization design, having developed the first BMS US regulatory organization.

Prior to joining YourEncore, Joe served as the US VP of Regulatory Sciences for Bristol Myers Squibb and VP of Regulatory Affairs with US and global experience for Schering Plough. In this role, Joe was responsible for leading the regulatory strategy for all global programs across the preclinical, clinical and approval stages.

Joe believes his ability to collaborate across matrixed organizations and maintain a sense of humor throughout the thrills and challenges of drug development have largely contributed to his success.

  • Graham Higson, Managing Expert, Regulatory Center of Excellence, YourEncore

Graham Higson has over 35 years of experience in the pharmaceutical industry. Since 2014, he has worked as a Regulatory consultant specializing in the provision of strategic regulatory advice, drug development, regulatory outsourcing and organizational development. Prior to his shift to consulting, he was Managing Director of NDA Advisory Services where he was accountable for the organization’s Regulatory and HTA Advisory Boards.

Early in his career, Graham was the Global Head of Regulatory Affairs for the medical diagnostics division of GE Healthcare and he spent five years at AstraZeneca as Vice President and Global Head of Global Regulatory Affairs, where he led the regulatory organisations across six R&D sites in the UK, Sweden, US and Japan. He held a number of senior regulatory positions in the UK and USA during his 11 year tenure at Pfizer, and he has also worked at Gensia, Sandoz, Ciba-Geigy, Synthѐlabo and Baxter Healthcare.

Graham has served on the EFPIA and PhRMA regulatory affairs committees, the CMR Regulations Advisory Board and the TOPRA Regulatory Advisory Council. He is also a member of the NDA Regulatory Advisory Board, comprised of former senior European regulators and industry experts.

  • Steve Pondell, Managing Expert, Regulatory Center of Excellence, YourEncore

Steve Pondell is a CMC expert in the manufacturing, compliance and regulatory aspects of product development from clinical manufacturing, through global regulatory approvals and into commercial production. He has experience working with small biotech companies as well as multi-national pharmaceutical companies, and has served as a contract manufacturer and as a virtual manufacturing outsourcing manager. His specialty is assisting companies work across the sponsor/contract manufacturing relationship, creating high performing partnerships on a global basis.

Steve presently serves as a Managing Expert, Regulatory Center of Excellence at YourEncore. As an expert consultant, Steve has helped a variety of small to medium sized pharma and biotech companies with projects that include GMP Gap Analyses, product development programs, CMC regulatory dossiers, cGMP compliance and supplier audits, and business development activities for a global logistics provider.

Webcast registration includes access to handouts, presentation slides and the on-demand recording for one year.

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