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Episode 4 - Pandemic Challenges & Agile Processes in Regulatory Affairs with Florin Muraru

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Manage episode 445729491 series 3609046
コンテンツは BioTalent Social によって提供されます。エピソード、グラフィック、ポッドキャストの説明を含むすべてのポッドキャスト コンテンツは、BioTalent Social またはそのポッドキャスト プラットフォーム パートナーによって直接アップロードされ、提供されます。誰かがあなたの著作物をあなたの許可なく使用していると思われる場合は、ここで概説されているプロセスに従うことができますhttps://ja.player.fm/legal

With a career spanning over two decades in the Pharma industry Florin Muraru is a Regulatory Affairs executive with exposure to all steps of the registration process for pharmaceutical products, including CTAs, CP, MRP, and national submission.
With an impressive strong regulatory expertise on drug development has vast experience in regulatory, cumulated more than 12 years in the Regulatory aspect of product development. Florin has the notable experience to develop and manage regulatory teams, in the last role had a major contribution to the successful implementation of an innovative, Regulatory HUB model service.
During this episode, we touched on the challenges that the global health crisis has created, how the regulatory landscape has enabled its processes to remain agile, and the impact the pandemic will have throughout 2020 and onwards. Florin believes his passion for regulatory affairs is based on the fact that he has the ability, based on clear rules to deliver an accessible product that provides medicine as fast as possible to patients, doctors, and clinical specialists.
Florin discusses the importance to use your knowledge to adapt to the climate to support products and therapies, adhere to regulatory guidelines, assist with the development of the product and address, solve and overcome challenges promptly. There are challenges every single day, with the unprecedented crisis creating many problems but also new unfamiliar obstacles. One of which includes the level of communication and the way discussions are presented to ensure it is understood when considering a good, strong, scientific proven argument for registering a new product or regulatory strategy.
The ability to adapt to the current climate is of utmost importance. A lasting impact for Florin, he has realised, there is no interest in profit within regulatory affairs, individuals in his field are commonly interested in alliance and the health and safety of their patients. The world and industry reacted rapidly to the pandemic, showing us that healthcare professionals will not sacrifice the quality of care over profitability. The lessons learned in the first wave of the pandemic, create a future based around enhanced collaboration and the agile development of future products and therapies.
Visit our website for more information: www.biotalent.com
#ItsInOurDNA

  continue reading

21 つのエピソード

Artwork
iconシェア
 
Manage episode 445729491 series 3609046
コンテンツは BioTalent Social によって提供されます。エピソード、グラフィック、ポッドキャストの説明を含むすべてのポッドキャスト コンテンツは、BioTalent Social またはそのポッドキャスト プラットフォーム パートナーによって直接アップロードされ、提供されます。誰かがあなたの著作物をあなたの許可なく使用していると思われる場合は、ここで概説されているプロセスに従うことができますhttps://ja.player.fm/legal

With a career spanning over two decades in the Pharma industry Florin Muraru is a Regulatory Affairs executive with exposure to all steps of the registration process for pharmaceutical products, including CTAs, CP, MRP, and national submission.
With an impressive strong regulatory expertise on drug development has vast experience in regulatory, cumulated more than 12 years in the Regulatory aspect of product development. Florin has the notable experience to develop and manage regulatory teams, in the last role had a major contribution to the successful implementation of an innovative, Regulatory HUB model service.
During this episode, we touched on the challenges that the global health crisis has created, how the regulatory landscape has enabled its processes to remain agile, and the impact the pandemic will have throughout 2020 and onwards. Florin believes his passion for regulatory affairs is based on the fact that he has the ability, based on clear rules to deliver an accessible product that provides medicine as fast as possible to patients, doctors, and clinical specialists.
Florin discusses the importance to use your knowledge to adapt to the climate to support products and therapies, adhere to regulatory guidelines, assist with the development of the product and address, solve and overcome challenges promptly. There are challenges every single day, with the unprecedented crisis creating many problems but also new unfamiliar obstacles. One of which includes the level of communication and the way discussions are presented to ensure it is understood when considering a good, strong, scientific proven argument for registering a new product or regulatory strategy.
The ability to adapt to the current climate is of utmost importance. A lasting impact for Florin, he has realised, there is no interest in profit within regulatory affairs, individuals in his field are commonly interested in alliance and the health and safety of their patients. The world and industry reacted rapidly to the pandemic, showing us that healthcare professionals will not sacrifice the quality of care over profitability. The lessons learned in the first wave of the pandemic, create a future based around enhanced collaboration and the agile development of future products and therapies.
Visit our website for more information: www.biotalent.com
#ItsInOurDNA

  continue reading

21 つのエピソード

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