"Formulating a Successful Regulatory Strategy"
Zintro Webinar
Presented by Parul Chansoria, Found and CEO - Elexes
Presenters Note:
"As the regulatory requirements constantly evolve and become increasingly complex, it is important for companies to formulate a thought through regulatory strategy rather than relying on a previously successful one. A strong regulatory strategy is very important for bringing new medical devices to the market".
In this webinar you will learn about:
· Aligning your regulatory strategy with corporate long-term and short-term goals
· Balancing between competing priorities
· Common strategy pitfalls to avoid
· Leveraging individual expertise for a successful strategy
About Parul:
Parul Chansoria is an experienced RAC and ICH GCP certified Regulatory Affairs Professional with a Bachelor’s in Bio-medical Engineering and a Master’s in Bioengineering from University of Illinois, Chicago. She is also a Certified Quality Auditor by American Society of Quality.
At the early stage of her career, Parul worked in Medical Device R&D where she built a micro device that created hypoxia in heart muscle cells and facilitated the study of Heart activity during Ischemia. From R&D Parul moved to regulatory, to utilize her Medical Device design, development and testing experience, and in-depth knowledge of Regulatory Affairs for bringing innovative Medical Devices to market.
As a Regulatory Professional, Parul advised many companies on bringing their Devices to the US and International markets and on maintaining compliance of existing devices for patient safety. Parul has worked with big and small US and UK based Medical Device companies like Stryker, Intuitive Surgical, UPL Distribution, etc on capital equipment, software, and single-use and reusable devices. She has worked with dialysis equipment, robotic and minimally invasive surgical devices, laser and radiological devices, and other diagnostic and therapeutic.
Видео "Formulating a Successful Regulatory Strategy" канала Zintro, Inc.
Presented by Parul Chansoria, Found and CEO - Elexes
Presenters Note:
"As the regulatory requirements constantly evolve and become increasingly complex, it is important for companies to formulate a thought through regulatory strategy rather than relying on a previously successful one. A strong regulatory strategy is very important for bringing new medical devices to the market".
In this webinar you will learn about:
· Aligning your regulatory strategy with corporate long-term and short-term goals
· Balancing between competing priorities
· Common strategy pitfalls to avoid
· Leveraging individual expertise for a successful strategy
About Parul:
Parul Chansoria is an experienced RAC and ICH GCP certified Regulatory Affairs Professional with a Bachelor’s in Bio-medical Engineering and a Master’s in Bioengineering from University of Illinois, Chicago. She is also a Certified Quality Auditor by American Society of Quality.
At the early stage of her career, Parul worked in Medical Device R&D where she built a micro device that created hypoxia in heart muscle cells and facilitated the study of Heart activity during Ischemia. From R&D Parul moved to regulatory, to utilize her Medical Device design, development and testing experience, and in-depth knowledge of Regulatory Affairs for bringing innovative Medical Devices to market.
As a Regulatory Professional, Parul advised many companies on bringing their Devices to the US and International markets and on maintaining compliance of existing devices for patient safety. Parul has worked with big and small US and UK based Medical Device companies like Stryker, Intuitive Surgical, UPL Distribution, etc on capital equipment, software, and single-use and reusable devices. She has worked with dialysis equipment, robotic and minimally invasive surgical devices, laser and radiological devices, and other diagnostic and therapeutic.
Видео "Formulating a Successful Regulatory Strategy" канала Zintro, Inc.
Показать
Комментарии отсутствуют
Информация о видео
Другие видео канала
"Starting a Business: Importing to the USA"FDA Regulatory Affairs Webinar - AsphalionHow to perform your Process Validation for medical devices? (IQ OQ PQ)Webinar | Digital Transformation - An Opportunity for Medical Affairs | Christiane Nina Belly, MSDICH M4-2. eCTDHow to learn the auditing standards EASILY! 4 top tips!Medical AffairsPlan B -- is there an alternative to economic growth?: Miklós Antal at TEDxDanubia 20141.Overview of the EMA and the centralised procedureHow Bed and Breakfast Owners make more money (and have more fun)OND Reorganization and the New Drugs Regulatory Program ModernizationMAA pre-submission issues and EMA meeting opportunitiesDesigning Your Career as a Regulatory ProfessionalWhat is a Medical Science Liaison? SALARY Inc! | Biomedical Science Jobs and Careers | Biomeducated"Starting to Export from the USA"MasterControl Quality Management System (QMS) DemoICH CTD QUALITY Part -CMC Module 3 Drug Substance Video by Rajashri Ojha at Raaj PharmaeLearningFDA 101 for Medical DevicesData Analytics for BeginnersInnovative Product Regulatory Strategies and Considerations for Medical Devices and IVDs