An Uncommon Expert

Aman Khera

Global Head of Regulatory Strategy

Aman Khera, Global Head of Regulatory Strategy at Worldwide Clinical Trials, has been providing global strategic direction in regulatory affairs for more than two decades. She has built her career on maintaining fastidious patient care with the pragmatism needed to help clients achieve effective regulatory strategies. Aman is available to consult with companies of all sizes, as well as their funding entities, to support their goals – with the primary aim of serving humanity as a whole.

A Message from Aman Khera:

COVID-19 has provided those of us in clinical research with incredible opportunities while simultaneously challenging the industry’s status quo. Here are a few trends that will remain constant through these rapid changes.

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Regulatory strategy needs to have a seat at the drug development table, from the beginning. Developing the product is only one aspect of clinical research. Do you have a regulatory strategy plan? You need to think about all of the puzzle pieces and make your transitions when there is a suitable inflection point. This will save you time and money.

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Diversity and inclusion is essential in today’s world. There continues to be a push for clinical trials in emerging markets due to cost, new diseases within the countries and populations with different indications. The time is now to take action.

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Science and medicine are drivers and technology is a tool. It’s a growing space and we should pay attention to its development. The use of AI and machine learning, for example, is only going to increase as the flow, availability, and accessibility of more data occurs in our industry.

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TOPICS AMAN COVERS:

• Regulatory strategy
• Diversity and inclusion in healthcare
• Focusing on the patient voice

ABOUT AMAN KHERA

Aman is the Global Head of Regulatory Strategy at Worldwide. She is an accomplished leader and expert in regulatory affairs, with a 22-year track record of success within the CRO environment in providing global strategic direction in regulatory affairs. She has led regulatory strategy and development services on a wide variety of regulatory projects for a variety of client sponsor companies, ranging from virtual companies to large companies in many therapeutic indications.

Aman is passionate about developing comprehensive strategies. Her career has been built on helping clients achieve their end-to-end regulatory strategies – from study submission to commercialization.

Aman joined Worldwide from a large global CRO, where, during her 17-year tenure, she led and developed many functions and services within regulatory, ranging from regulatory intelligence to business development and streamlining the many initiatives to develop regulatory services, most recently holding the position of Head of Americas for the Regulatory Strategy and Agency Liaison team. As a change maker, she is passionate about the “people” aspect of the CRO business as well as strategic operations in building, engaging, and retaining teams and how this translates to a positive impact on healthcare.

She is an active volunteer in regulatory associations; she served on the editorial panel of the peer-reviewed journal, the Regulatory Rapporteur, as well as currently serves as Chair of the North American Chapter for The Organization for Professionals in Regulatory Affairs (TOPRA). Aman is also a member of the TOPRA Diversity Committee and has taken a special interest in diversity and inclusion within industry. In 2017, Aman was shortlisted for an industrywide Regulatory Excellence award in the Inspiration category. This year, she has joined the esteemed and distinguished luminary panel of judges for the Excellence Awards.

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