June 14th 2021 16:00 Gulf Standard Time| 45 Mins Webinar
Trends in global API suppliers and the key to strategic success in MENA regulatory affairs
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Join us for this two-part webinar on Monday 14th June, 16.00 - 16.45 Gulf Standard Time where delve into 1) Global API Supplier Trends, the impact of COVID-19 on the API industry and the way forward and 2) Success in Regulatory Affairs, how to unlock a well-defined, multinational regulatory strategy with a MENA focus.
This webinar will be useful for heads and decisions-makers of Generics, APIs, Regulatory and Pharma Supply Chain.
This webinar will be useful for heads and decisions-makers of Generics, APIs, Regulatory and Pharma Supply Chain.
Part 1: Global API Supplier Trends (15 mins)
Demand for generic drugs has continued to grow across the globe, as cash-challenged payers are dealing with ageing populations and increased need for medicines, providing API manufacturers with opportunities to supply. However, generics continue to face margin pressure, impacting API prices in turn, while requiring higher quality and regulatory accreditation than ever before.
In order to prosper, API manufacturers should understand which customers, geographies, and types of products drive the demand for APIs. Those variables will determine what kinds of capabilities and capacities manufacturers will need to invest in and where those investments need to take place.
Part 2: Success in Regulatory Affairs (20 mins)
The pandemic has created many unforeseen challenges in adapting regulatory strategies to meet the needs of the day. Without a sound strategy, you will struggle to get your life saving treatment approved and to patients both globally and within the MENA region. This limits both patient access to medicines your company creates as well as limiting commercial success.
Educating your RA team and aligning your regulatory strategy across critical functions is key to driving success. By breaking down the process into manageable chunks, your RA team can take the lead in crafting a robust strategy interlinked with competitive analysis exploring both global and local competition.
For the second part of the webinar, join the former regulatory intelligence lead at Gilead Sciences to uncover how you can design your regulatory strategy efficiently and confidently.
Live Q&A (10 mins)
Attendees will have the opportunity to ask our experts questions related to their API and regulatory strategy at the end of the webinar. You can also send us your questions in advance by filling the form on the right-hand side.
Demand for generic drugs has continued to grow across the globe, as cash-challenged payers are dealing with ageing populations and increased need for medicines, providing API manufacturers with opportunities to supply. However, generics continue to face margin pressure, impacting API prices in turn, while requiring higher quality and regulatory accreditation than ever before.
In order to prosper, API manufacturers should understand which customers, geographies, and types of products drive the demand for APIs. Those variables will determine what kinds of capabilities and capacities manufacturers will need to invest in and where those investments need to take place.
Part 2: Success in Regulatory Affairs (20 mins)
The pandemic has created many unforeseen challenges in adapting regulatory strategies to meet the needs of the day. Without a sound strategy, you will struggle to get your life saving treatment approved and to patients both globally and within the MENA region. This limits both patient access to medicines your company creates as well as limiting commercial success.
Educating your RA team and aligning your regulatory strategy across critical functions is key to driving success. By breaking down the process into manageable chunks, your RA team can take the lead in crafting a robust strategy interlinked with competitive analysis exploring both global and local competition.
For the second part of the webinar, join the former regulatory intelligence lead at Gilead Sciences to uncover how you can design your regulatory strategy efficiently and confidently.
Live Q&A (10 mins)
Attendees will have the opportunity to ask our experts questions related to their API and regulatory strategy at the end of the webinar. You can also send us your questions in advance by filling the form on the right-hand side.
We will be covering the following topics:
API trends
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An overview of the global API suppliers
API trends
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A deep dive into where top API manufacturers are located, their capabilities, and proficiency in specific product classes with a lens on the MENA and nearby regions
API trends
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A look at the impact COVID-19 has had on supply chains and the API manufacturing industry
API trends
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Tips to identify and evaluate potential portfolio candidates based on industry needs and trends in the MENA region
Regulatory strategy
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What is the definition of a regulatory strategy?
Regulatory strategy
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What are common global and MENA challenges and how can we overcome them?
Regulatory strategy
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How can we provide a pathway for continual improvement across our organization?
Regulatory strategy
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How can we begin to implement these changes within our organization?
Our talented speakers are experts in generics and regulatory intelligence:
SAM KAY
Solutions Consultant, Clarivate
Sam specializes in regulatory intelligence. Sam Joined Clarivate recently after holding multiple roles in regulatory intelligence and strategy across multiple large and small pharma companies. Sam’s main goal is to bring regulatory affairs into a more strategic focus through high quality intelligence across the industry, enabling rapid access of life saving medicines and medical devices across the globe.
Nicole Reynolds
Solutions Consultant, Clarivate
Nicole has worked within the pharmaceutical industry for over 20 years. Leveraging Competitive Intelligence, Translational Research, Regulatory Intelligence and Generics Intelligence, Nicole partners with Life Science companies across the globe to understand their challenges, guide them through the intricacies of the pharmaceutical industry and connect them with best practice solutions to meet their needs. Nicole holds a Masters in Science Education from Widener University.
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