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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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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This course highlights the requirements and importance of an effective postmarket surveillance program that satisfies the regulatory and quality system requirements in the US, Canada and Europe.
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Regulation of US & EU Biologics [5.0 RAC]
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This course examines the special characteristics of biologic products and the challenges associated with their development in the US and EU.
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This course provides a solid understanding of medical device regulation in the EU. It covers the history of medical device regulation in Europe and follows the regulatory requirements throughout the product life.
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This course provides a basic understanding of current Good Manufacturing Practice (CGMP) regulations and their impact on product quality and patient safety.
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This course identifies the regulations on the proper conduct of clinical research with human subjects that were put in place due to ethical issues in human research.
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Driving Innovation: Planning for CTD Submissions with Language Excellence
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Language service providers can help pharmaceutical companies navigate CTD submissions required by recent regulatory changes in APAC countries such as China.
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Building Global Submissions from the Ground Up - SARS-CoV-2 Case Study
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Whether you are developing SARS-CoV-2 assays or are just interested how to efficiently build your global submissions, this webcast aims to share some of those best practices using SARS-CoV-2 as a case study.