Regulatory NewsRegulatory News
This Week at FDA: Generic drug approvals continue downward trend, new guidance on clinical trial diversity coming
Posted 21 January 2022 By Michael Mezher
Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation and what we’re reading from around the web. This week, we look at some newly published data f...
Regulatory NewsRegulatory News
European Parliament endorses legislation bolstering EU’s ability to tackle shortages
Posted 20 January 2022 By Joanne S. Eglovitch
The European Parliament approved legislation to increase the powers of the European Medicines Agency (EMA) in monitoring and responding to drug and device shortages.
RoundupsRoundups
Euro Roundup: MHRA seeks feedback on proposals for the future of UK clinical trial legislation
Posted 20 January 2022 By Nick Paul Taylor
The Medicines and Healthcare products Regulatory Agency (MHRA) is holding a consultation into the future of clinical trial legislation in the UK. MHRA is seeking feedback on tens of proposals intended to streamline processes and remove u...
Regulatory NewsRegulatory News
EU launches clinical trials transformation initiative
Posted 18 January 2022 By Joanne S. Eglovitch
The EU has just kicked off a new initiative meant to transform how clinical trials are initiated and run to promote clinical research in the region. The initiative is meant to address “a relative absence of EU impactful multi-state trial...
Regulatory NewsRegulatory News
GAO tasks FDA with developing agency-wide workforce plan for medical product staff
Posted 17 January 2022 By Jeff Craven
Centers within the US Food and Drug Administration (FDA) are using the flexibility in hiring and pay requirements afforded by the 21st Century Cures Act (Cures Act) to recruit and retain medical staff, but the agency does not have a wo...
RoundupsRoundups
Euro Roundup: EDQM pushes forward with ‘CEP of the future’ after positive feedback
Posted 13 January 2022 By Nick Paul Taylor
The European Directorate for the Quality of Medicines (EDQM) will spend the first half of 2022 designing the Certificate of Suitability (CEP) after a consultation revealed support for its plan to revise the content and layout document.
Regulatory NewsRegulatory News
IVDR: European Commission publishes second batch of harmonized standards
Posted 11 January 2022 By Michael Mezher
On Thursday, the European Commission officially recognized five additional harmonized standards for in vitro diagnostics in order to satisfy conformity requirements under the In Vitro Diagnostic Medical Devices Regulation (IVDR).
RoundupsRoundups
Asia-Pacific Roundup: TGA seeks feedback on planned adoption of 19 international guidance documents
Posted 11 January 2022 By Nick Paul Taylor
Australia’s Therapeutic Goods Administration (TGA) is holding a consultation about plans to adopt 19 international scientific guidelines. TGA wants to know whether stakeholders support the adoption of the European Medicines Agency (EMA) ...
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Executive Development Program at the Kellogg School of Management
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Software as a Medical Device
Tuesday, 18 October 2022 (9:00 - 5:00PM) 12.0 RAC Credits Members: € 945 Nonmembers: € 1,120
Review current and evolving regulatory requirements for software as a medical device in order to navigate the challenging expectations for software products.
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Cybersecurity Unauthorized
Tuesday, 08 March 2022 (10:00 - 5:00PM) 12.0 RAC Credits Members: $970 | Nonmembers: $1,150
This workshop will help regulatory and quality professionals develop the knowledge they need to help steer their organizations in the right direction when it comes to global cybersecurity expectations.
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Software as a Medical Device
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Join regulatory experts to explore evolving global regulatory requirements affecting SaMD, including determining when software is considered regulated as SaMD and how to determine correct class/classification.
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Biologics CMC: Phase Appropriate Product Development
Thursday, 17 March 2022 (9:00 - 4:00PM) 12.0 RAC Credits Member: $825 | Nonmember: $970
Learn how to handle technical issues affecting biologic product development challenges and expectations in the US, Europe, and other highly regulated regions.
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Biologics CMC: Regulatory Challenges and Trends
Thursday, 19 May 2022 (9:00 - 4:00PM) 12.0 RAC Credits Member: $825|Nonmember: $970
Overview of chemistry, manufacturing and control (CMC) regulatory requirements and best practices associated with biologic and biosimilar products. Emphasis on requirements in US, Europe, and other regulated regions.
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Biologics CMC: Phase Appropriate Product Development
Thursday, 21 July 2022 (9:00 - 4:00PM) 12.0 RAC Credits Member: $825 Nonmember: $970
Learn how to handle technical issues affecting biologic product development challenges and expectations in the US, Europe, and other highly regulated regions.
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Biologics CMC: Phase Appropriate Product Development
Thursday, 08 December 2022 (9:00 - 4:00PM) 12.0 RAC Credits Member: $825 | Non-member: $970
Learn how to handle technical issues affecting biologic product development challenges and expectations in the US, Europe, and other highly regulated regions.
     
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China NMPA Clinical Evaluation and Trial Key Changes to Support Order 739 Webcast
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This webcast will explore the evolving regulations for China NMPA, reviewing regulations related to clinical evaluation, the main changes under Decree #739 in areas of clinical evaluation pathways.
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SaMD Product Development: Addressing Challenges through Early Integration of Regulatory, Quality and Clinical Data Strategies
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This webcast will focus on best practices and proven strategies to address challenges presented by today’s shifting SaMD regulatory environment, and discuss the keys to commercial success.
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Meet the Authors, Regulatory Writing, Second Edition
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Hear from the experts who wrote the book on regulatory writing. Authors Lisa DeTora, Jocelyn Jennings and Jenny Grodberg will discuss the new edition’s writers-eye view of regulatory documentation.
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PMS Requirements of the EU MDR: Implementation Challenges and Solutions
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This webcast will go into detail about strategies to overcome audit findings and gaps in your evidence.
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Ethics--Essential Tools for Regulatory Professionals [4.0 RAC]
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This course identifies and analyzes ethical issues regulatory professionals may encounter and provides a general introduction to complex concepts, principles and theories, including bioethics and legal principles.
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Sponsored Webcast: Making Sense of FDA's 2021 Real-World Evidence Guidance (On-Demand)
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As one of the leading Notified Bodies in these transition cases, BSI will share a series of lessons learned from actual case reports of manufacturers moving through the transitioning to applying the EU MDR
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China NMPA (CFDA) Regulatory Approval: Clinical Evaluation and Pathways
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This workshop will cover different clinical evaluation and pathways and how to decide which pathway to choose to support China NMPA medical device/IVD regulatory approval or postmarket study requirements.
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Impact of MDR on Drug-Device Combination Products: Notified Body Opinion and CE Mark Applications (On-Demand)
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Learn how EU MDR 2017/745 affects integral drug-device combinations and how to develop a complete dossier for Notified Body review.