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It didn’t all change in March 2020. Not really. The UK high street has been in the throes of a gradual revolution for decades. From the rise of ecommerce, to the birth of mobile, social commerce, and a growing emphasis on experience, change has been underway for a while. In fact for many, the pandemic has acted as a wake-up call. Digital transformation was no longer a ‘nice to have’ but a matter of survival. Necessity sparked innovation and customers are enjoying more flexibility and conveni ...
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Developing a Regulatory Strategy
Manage episode 347870072 series 1017311
Thông tin tác giả Greenlight Guru + Medical Device Entrepreneurs, Executives, Inventors & Consultants; R&D, Quality, Regulatory, Greenlight Guru + Medical Device Entrepreneurs, and Consultants; R được phát hiện bởi Player FM và cộng đồng của chúng tôi - bản quyền thuộc sở hữu của nhà sản xuất (publisher), không thuộc về Player FM, và audio được phát trực tiếp từ máy chủ của họ. Bạn chỉ cần nhấn nút Theo dõi (Subscribe) để nhận thông tin cập nhật từ Player FM, hoặc dán URL feed vào các ứng dụng podcast khác.
What is a regulatory strategy? And for that matter, what do people sometimes think is a regulatory strategy but isn’t? Those are the questions that today’s guest, Mike Drues, discusses as he begins his conversation with host John Speer, founder of Greenlight Guru.
Mike is President of Vascular Sciences, an education, training, and consulting company that offers many services to medical device, pharmaceutical, and biotechnology companies. Listen to the episode to learn how Mike thinks about competitive regulatory strategy, delays in complying with regulation, and reimbursement and regulatory strategy.
Some of the highlights of this episode include:
- What regulatory strategy is and what it isn’t
- Why a good regulatory strategy is so important
- What competitive regulatory strategy is
- The mistake of focusing on only one company
- How the EU MDR is affecting regulatory strategy
- What causes delays in complying with regulations
- The industry record on post-market surveillance
- Reimbursement and regulatory strategy
Memorable quotes from Mike Drues:
“Let’s not forget my old friend, competitive regulatory strategy.”
“It’s never too soon, in my opinion, to start thinking about regulatory strategy.”
“As a general rule, we have done an abysmal job on post-market surveillance across the board.”
“I consider this whole thing to be a poker game, in every sense of the word.”
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