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
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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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Biologics CMC: Phase Appropriate Product Development
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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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Navigating Today’s Regulatory Trends to Successfully Manage eCTD Submissions
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This webcast will feature an overview of best practices to create successful eCTD submissions in a rapidly changing environment.
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Strategies for Successful PMCF Planning and Execution
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Walks you through a clear process for ensuring your PMCF planning is effective and efficient, beginning with an overview of what's required and how to evaluate your current state against the requirements.
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2020 NMPA (CFDA) Key Updates and Look Ahead on 2021
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How can manufacturers or inventors be proactively prepared to shorten their time to market for new submissions, allow enough lead time for renewal, and to know when to file for modifications to avoid penalties?
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A Risk-Based Approach to Validation for Life Sciences Companies
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Learn how a risk-based validation approach can meet compliance requirements and maintain quality while streamlining the validation process.
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Argumentation and Persuasion for Regulatory Professionals
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Giving Voice to Regulatory Leadership
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This course provides an overview of GLP regulations as they are applied and interpreted by the FDA, EPA and the Organization for Economic Cooperation and Development.
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IVDR 2022: What IVD manufacturers can learn from the MDR rollout
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This webcast will cover the potential impact of IVDR implementation in 2022 for new and existing (legacy) devices and considerations learned from the MDR rollout for IVD manufacturers to consider strategy.