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.
ReconRecon
Recon: 27 firms to manufacture Merck’s COVID pill; Blood sample collection tubes land on FDA device shortage list
Posted 20 January 2022 By Joanne S. Eglovitch
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Regulatory NewsRegulatory News
FDA offers examples of innovative study designs accepted into CID pilot
Posted 20 January 2022 By Joanne S. Eglovitch
The US Food and Drug Administration (FDA) recently highlighted three case studies showing how sponsors can incorporate innovative study designs in their clinical trials using the agency’s Complex Innovative Trial Designs (CID) pilot meet...
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...
RoundupsRoundups
FDA Approvals Roundup: Ryaltris, Cibinqo, Rinvoq
Posted 19 January 2022 By Renee Matthews
A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).
ReconRecon
Recon: Pfizer says Paxlovid appears effective against omicron; Unilever ends pursuit of GSK consumer arm
Posted 19 January 2022 By Joanne S. Eglovitch
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Regulatory NewsRegulatory News
FDA extends temporary halt in inspections driven by omicron
Posted 19 January 2022 By Michael Mezher
The US Food and Drug Administration (FDA) has extended its temporary pause on non-mission-critical domestic surveillance inspections through 4 February 2022, an agency spokesperson told Focus on Wednesday.
Regulatory NewsRegulatory News
Califf, experts eye legislative fix for accelerated approval program
Posted 19 January 2022 By Mary Ellen Schneider
Regulatory and industry experts agree that completing confirmatory studies quickly is essential to the success of the US Food and Drug Administration’s (FDA) accelerated approval program, with some suggesting that new legislation might b...
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Cybersecurity
Tuesday, 18 October 2022 (9:00 - 5:00PM) 12.0 RAC Credits Members: € 945 Nonmembers: € 1120
Gain the knowledge you need to navigate global cybersecurity expectations, translate regulatory expectations into concrete design and development activities and establish trust with customers.
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Sponsored Webcast: E-labeling and Legislation: A Positive Impact on Patient Safety and Sustainability
Wednesday, 23 February 2022 (12:00 - 1:00PM) 1.0 RAC Credits Members: $0 | Nonmembers: $0
Attend this live broadcast and learn the essentials of e-PIL legislation, a pilot initiative between the pharm industry and regulatory authorities in Belgium and Luxembourg, supported by the European Commission
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COVID-19 In Vitro Diagnostics: A Look into FDA’s Regulatory Response
Thursday, 10 February 2022 (1:00 - 2:00PM) 1.0 RAC Credits Members $0 | Nonmenbers $0 This presentation will discuss the FDA Emergency Use Authorization Guideline and how the guidance has changed over time.
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RA Considerations During Clinical Development in the EU
Thursday, 17 February 2022 (8:30 - 4:00PM) 6.0 RAC Credits Members: € 555 | Nonmembers: € 650
Learn which aspects to consider when writing a regulatory plan, along with several pathways to speed up development, including PRIME and adaptive pathways.
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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: 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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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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How to Better Manage Quality and Risk with a Global Change Control Strategy
1.5 RAC Credits
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Learn about the contributing factors to building change control system that can help manage risk as well as metrics to consider to drive success.
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Medical Device Certificate Elective Medical Device Certificate Elective
Quality System Regulation (QSR) [5.0 RAC]
5.0 RAC Credits
Member: $545.00 Nonmember: $745.00
This course is organized to align with the organization of the subparts and paragraphs as presented in the QSR.
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Sponsored Webcast: Combination Products: Regulatory Approach and cGMP Requirements (On-demand)
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
This webinar will walk you through the regulatory approach and the new regulations applied for combination products.
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How to Transform Quality and Regulatory Programs from Cost Centers to Profit Centers
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
The webcast features lessons learned from the COVID-19 pandemic about leveraging risk management and quality management systems to maximize business success in times of disruption and digital transformation.
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Quality Management Systems for Drugs and Devices
Member: $205.00 Nonmember: $285.00
Quality Management Systems for Drugs and Devices presents a comprehensive overview of quality management systems, including quality assurance, GMP, GLP, GCP, and compliance.
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Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Good Manufacturing Practice (GMP) [4.0 RAC]
4.0 RAC Credits
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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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Complete WHO Guidance Documentation Bundle
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A WHO bundle with six guidance documents addressing pharmaceuticals, medical devices, psychotropic substances and plasma.
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Good Laboratory Practice (GLP) [3.0 RAC]
3.0 RAC Credits
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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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Medical Device Certificate Elective Medical Device Certificate Elective

Quality System Regulation (QSR) [5.0 RAC]

5.0RAC Credits
Member: $545.00 Nonmember: $745.00
This course is organized to align with the organization of the subparts and paragraphs as presented in the QSR.
On-demand On-demand

Sponsored Webcast: Combination Products: Regulatory Approach and cGMP Requirements (On-demand)

1.0RAC Credits
Member: $0.00 Nonmember: $20.00
This webinar will walk you through the regulatory approach and the new regulations applied for combination products.
On-demand On-demand

How to Transform Quality and Regulatory Programs from Cost Centers to Profit Centers

1.0RAC Credits
Member: $0.00 Nonmember: $20.00
The webcast features lessons learned from the COVID-19 pandemic about leveraging risk management and quality management systems to maximize business success in times of disruption and digital transformation.