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Missed the webinar or wish to revisit the discussion? Kevin Leland: Do you find that these tech landscapes are any materially different whether you’re talking about packaging, gene therapy, or women’s health, for example, or do they all follow the same format? The landscapes are really custom to the needs of the customer.
This joint webinar presentation by West and Groninger, explores the unique challenges of Cell and Gene Therapies, mRNA LNP therapeutics particularly regarding cold storage requirements and their impact on packaging solutions. Click here to login. Listing Image WestPharma_ListingLogo_250x190.png
Innovations in aseptic processing for container closure systems dwunderlin Fri, 01/03/2025 - 14:26 Wed, 02/12/2025 - 10:00 Resource Type Webinar Jim Thompson Julian Petersen Duration 60 Minutes The pharmaceutical landscape is shifting from blockbuster drugs to personalized treatments, driving the need for innovative container closure systems.
png Listing Introduction Join West experts to learn about solutions for today’s drug products and tomorrow’s novel applications and gain insights to understand and execute a risk-based critical thinking approach related to injectable drug packaging and delivery. Listing Image WestPharma_ListingLogo_250x190.png
In this webinar, you will learn about: The challenges and risks related to the packaging and filling of high-value drug products. West Pharmaceutical Services (West) and Cytiva have teamed up to offer innovative and versatile fill finish solutions to efficiently meet the unique demands of advanced pharmaceutical applications.
Developing and Manufacturing Minitablets to Extend Drug Lifecycle pesurya Fri, 01/12/2024 - 12:38 Wed, 02/28/2024 - 11:00 Resource Type Webinar Robert Strickley, PhD Valjon Demiri, MSc Duration 60 Minutes Oral minitablets can offer several advantages in pharmaceutical applications, making them a valuable option in drug delivery.
Sterilization also takes place after formulation, once the product has been filled into the primary packaging, making it the optimal choice. Learn more about our expertise and find out if terminal sterilization is suitable for your product. Speak with one of our experts.
This recurring feature compiles information from across EU agencies and institutions to deliver an overview of chemicals-related regulatory actions likely to happen in the month ahead, including planned legislation, consultations, webinars, meetings, and more.
Advarra experts Sharon Ayd and Leslie Paul answer questions from their webinar, The IND Journey Phase I – Navigating Success. Q: What is the typical time period between the submission of the briefing package and the pre-IND meeting? Q: The speaker just stated that the Meeting Package is due 60 days before the meeting date.
In the same month, the California Department of Toxic Substances Control (DTSC) presented its chemical profile for carpets and rugs containing PFAS as well as a webinar for its findings on PFAS in food packaging. Since that time, the EPA has published additional drafts of the PHGs.
This ongoing feature compiles information from across EU agencies and institutions to deliver an overview of chemicals-related regulatory actions likely to happen in the month ahead, including planned legislation, consultations, webinars, meetings, and more. Consultations are held to allow interested parties to contribute to this process.
This recurring feature compiles information from across EU agencies and institutions to deliver an overview of chemicals-related regulatory actions likely to happen in the month ahead, including planned legislation, consultations, webinars, meetings, and more. regulation, directive, decision). regulation, directive, decision).
Advarra expert Steffen Engel answers questions from the recent webinar, Stepwise Implementation of a Clinical Quality Management System. A: The webinar discussed the following factors: Conduct a thorough assessment of each site’s QMS. A: That is a tough one. First, congratulations on realizing such a mindset may exist.
This recurring feature compiles information from across EU agencies and institutions to deliver an overview of chemicals-related regulatory actions likely to happen in the month ahead, including planned legislation, consultations, webinars, meetings, and more. food packaging, kitchen and tableware and food processing equipment).
2 However, utilisation of biological systems introduces variability and by-products, as well as a challenge unique to AAV production: the assembly of full capsids with correctly packaged DNA, partially filled capsids containing partial vector and/or host cell DNA, and empty capsids.
This recurring feature compiles information from across EU agencies and institutions to deliver an overview of chemicals-related regulatory actions likely to happen in the month ahead, including planned legislation, consultations, webinars and meetings. food packaging, kitchen and tableware and food processing equipment).
This ongoing feature compiles public information from across the EU to deliver an overview of all the chemical policy-related actions in the month ahead, including planned legislation, consultations, webinars, meetings, and more. food packaging, kitchen and tableware and food processing equipment).
Start Date End Date Event Event Type Center 04/29/2024 04/29/2024 Medical Device Sterilization Town Hall: Topics and Formats for the Continuing Sterilization Series Town Hall CDRH 04/30/2024 04/30/2024 Webinar – Draft Guidance: Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act Webcast CDRH 05/01/2024 05/01/2024 (..)
This ongoing feature compiles information from across EU agencies and institutions to deliver an overview of chemicals-related regulatory actions likely to happen in the month ahead, including planned legislation, consultations, webinars, meetings, and more. food packaging, kitchen and tableware and food processing equipment).
This ongoing feature compiles information from across EU agencies and institutions to deliver an overview of chemicals-related regulatory actions likely to happen in the month ahead, including planned legislation, consultations, webinars, meetings, and more. food packaging, kitchen and tableware and food processing equipment).
Start Date End Date Event Event Type Center 07/10/2024 07/10/2024 Medical Device Sterilization Town Hall: Mock Pre-Submission on Implementing a Change in Sterilization Method Webcast CDRH 07/10/2024 07/10/2024 FDA Oncology Center of Excellence Presents: Conversations on Cancer: “Exploring Religious Literacy and Spirituality in Cancer Care” Webcast (..)
This ongoing feature compiles information from across EU agencies and institutions to deliver an overview of chemicals-related regulatory actions likely to happen in the month ahead, including planned legislation, consultations, webinars, meetings, and more. food packaging, kitchen and tableware and food processing equipment).
In an effort to further explain its current views on potency assurance, the FDA also recorded a webinar to accompany the new draft. Per the pre-recorded webinar that was posted alongside the draft guidance, it seems that the FDA’s intent was to streamline requirements for sponsors, not increase them.
December 2023 Fixed-Combination and Co-Packaged Drugs: Applications for Approval and Combinations of Active Ingredients Under Consideration for Inclusion in an Over-the-Counter Monograph (Final Rule) The final rule amends FDA regulations on fixed-combination prescription and nonprescription drugs.
Date Group Event Notable FDA Speakers August 5 Sentinel Overview of CDER’s Real-World Evidence Demonstration Projects August 12-14 Pharma Conference Education GMP By The Sea Peter Marks, Emily Thakur, Alonzo Cruse, Numerous others August 20 Duke-Margolis Continual Improvement of CDER BLA Submission, Assessment, and Facility Readiness/ Inspection: (..)
Those that might be appropriate include changes to design (dimensions, performance specifications, wireless communication, components/accessories, user interface), sterilization, transport, expiration dating or packaging (using well-established methods), materials or components (including reagents), software changes related to compatibility or interoperability, (..)
In the same month, the California Department of Toxic Substances Control (DTSC) presented its chemical profile for carpets and rugs containing PFAS as well as a webinar for its findings on PFAS in food packaging.
The way this was done, was through webinars. I know you may be asking, “What is a webinar”? A webinar is an online video presentation that is focused on great practical information which you sit back and view on your PC, Mac, iPod or iPad. Plus, most webinars you canâ??t I was at a fitness site and watched a free webinar.
To receive updates when new versions of ChEMBL are available, please sign up to our mailing list: [link] # To receive updates about submitting your data to ChEMBL, please sign up to our deposition mailing list: [link] # For general queries/feedback please email: chembl-help@ebi.ac.uk # For details of upcoming webinars, please see: [link]
Many of these webinars and trainings sessions are geared towards medical devices and in vitro diagnostics (IVDs). Even small changes in the Parliament’s composition could have an impact on ongoing legislative discussions, such as the revisions to the pharma reform package.
Commission unveils “one substance, one assessment” reform package The Commission has long aspired to realize its one substance, one assessment concept in the EU’s chemical regulatory regime. Analysis One wonders what role the envisioned ECHA basic regulation will have in supporting this reform package.
Many of these are webinars and/or trainings sessionsfor new digital platforms. The pharma reform package remains in E.U. In the interim, the European Council will continue to discuss the package, and stakeholders may gain some insight into the Council’s thinking near the end of May. On April 10, the E.U.
A wide range of other meetings that will be occurring this month, with various webinars, committee meetings, and workshops spanning a variety of topics. Upcoming Webinar Hosted by Xtalks Webinar/Seminar ( OPEN) Xtalks 11/6/2023 11/6/2023 What is the evidence for high-risk medical devices in the field of cardiovascular disease and diabetes?
Major European regulators, national competent authorities, and interest groups are planning on hosting several webinars and trainings throughout August and September. Speaking of policy, legislative affairs will also likely pick up.
agencies and institutions to deliver insight into what chemicals-related regulatory actions are likely to happen in the month ahead, including planned legislation, consultations, webinars, meetings, and more. food packaging, kitchen and tableware and food processing equipment). which concluded its position on the proposal last June.
EPA also held a public webinar to provide an overview of the TSCA risk management process including the findings in the Part 1 risk evaluation. In addition, EPA published a notice of data availability on March 17, 2023 to solicit public comments on additional data received by EPA related to the proposed rule.
December 2023 Fixed-Combination and Co-Packaged Drugs: Applications for Approval and Combinations of Active Ingredients Under Consideration for Inclusion in an Over-the-Counter Monograph (Final Rule) The final rule amends FDA regulations on fixed-combination prescription and nonprescription drugs. Prohaska, Kavita C.
The supplemental proposal narrowed certain proposed exemptions for entities subject to the EPA-initiated risk evaluation fees and proposed exemptions for the test rule fee activities; proposed modifications to the self-identification and reporting requirements for EPA-initiated risk evaluation and test rule fees; proposed a partial refund of fees for (..)
For this routine MUR, EPA will only consider new methods or method revisions for which a complete, acceptable method package has been received by January 7, 2022. EPA also held a public webinar to provide an overview of the TSCA risk management process including the findings in the Part 1 risk evaluation.
This package would propose updates to the alternative work practice as appropriate based on the review and address the issues raised for reconsideration. Webinar American Chemistry Society 12/12/2023 AgencyIQ Chemicals webinar: U.S.
For this routine MUR, EPA will only consider new methods or method revisions for which a complete, acceptable method package has been received by January 7, 2022. EPA also held a public webinar to provide an overview of the TSCA risk management process including the findings in the Part 1 risk evaluation.
For this routine MUR, EPA will only consider new methods or method revisions for which a complete, acceptable method package has been received by January 7, 2022. EPA also held a public webinar to provide an overview of the TSCA risk management process including the findings in the Part 1 risk evaluation.
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