Navigating Regulatory Submissions with Science-Backed Strategies

Life Sciences, Pharmaceutical Regulation,
  • Tuesday, April 18, 2023

The regulations governing drugs are built on the science employed in the development of these products. Worldwide, regulators find that submissions that correctly and easily describe the science behind a product are easier to read and agree with. In this webinar, ProPharma, the leading RCO, will explore how their mantra of “good science presented well” has ensured success when conducting clinical trials and preparing regulatory submissions.

It is important to work with clients to design studies that put client products in the best scientific light. For example: focusing on the optimal statistical process, the best animal model or the correct pharmacodynamic model. When working with regulators, science-based conversations have the best results. The featured speakers will talk about using the combined expertise of their clinical research and regulatory sciences groups to navigate any regulatory hurdles.

Register now to discover how a science-backed strategic approach always generates the best results and delivers successful regulatory submissions, ultimately speeding products to market in the most effective manner.


Matthew Weinberg-150

Matthew Weinberg, President, Regulatory Sciences, ProPharma

Matthew Weinberg leads the Regulatory Sciences team at ProPharma, focusing on client management, client satisfaction and strategic growth. The group helps clients clear regulatory hurdles as they develop and market drugs, biologics and medical devices.

As CEO of The Weinberg Group, until its acquisition by ProPharma in 2019, Matthew was responsible for the growth and success of the firm — driving strategic expansion plans, acquisitions and personnel development. He led the firm in its expansion into non-US markets and aligned market segments such as GxP auditing.

Matthew created and chaired Building STEPS, a non-profit organization providing inner city children an opportunity to go to college and explore career opportunities in science. He has served on numerous Jewish community boards and is a fellow of the Wexner Heritage Foundation.

Message Presenter

Sharon Charles, RN, MBA, VP, Clinical Operations, ProPharma

Sharon is ProPharma’s VP, Clinical Operations based in Australia. With 25 years’ experience in the clinical development sector within APAC and across geographies and functions, Sharon has led corporate growth and developed world-class products and services. Sharon is a member of the Australian R&D Taskforce and AusBiotech Clinical Trials Advisory Committee, providing industry input to the Australian government policies and initiatives relating to the sector. She has been responsible for global clinical development leadership and planning, and oversight of clinical research projects, across a broad range of technologies including large and small molecules, cell therapies and devices, for adult, pediatric, prevalent and rare diseases.

Message Presenter

Who Should Attend?

Emerging pharma and biotech companies that are planning:

  • US Food and Drug Administration (FDA) submissions (IND, NDA, BLA)
  • FDA Meetings (INTERACT, Pre-IND, End of Phase 2, Pre-BLA, Pre-NDA, Type A, Type C, etc.)

Job Roles:

  • Chief Executive Officer
  • Chief Operating Officer
  • Chief Scientific Officer
  • Chief Medical Officer
  • VP/Director Regulatory Affairs

What You Will Learn

Attendees will gain insights into:

  • Using science to navigate the global regulatory maze
  • Common submission points that people get wrong
  • Using science to better define the benefit:risk profile of a medicine product
  • Real life examples of failed US Food and Drug Administration (FDA) drug applications or negative opinions given by the European Medicines Agency (EMA)

Xtalks Partner


For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world’s largest RCO (Research Consulting Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

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