Agency IQ

MAY 31, 2024

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.

Regulations 40

Regulations Production Compliance Pharmaceuticals 40

Agency IQ

MAY 3, 2024

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.

Regulations 40

Regulations Clinical Trials Production Biosimilars 40

Agency IQ

AUGUST 2, 2024

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.

Regulations 40

Regulations Clinical Trials Production Trials 40

Agency IQ

MAY 3, 2024

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.

Regulations 40

Regulations Packaging Production International 40

The ChEMBL-og

JUNE 13, 2023

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]

Pharmacokinetics 97

Pharmacokinetics FDA Approval International Production 97

Advarra

JULY 19, 2022

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.

Packaging 52

Packaging FDA Trials Regulations 52

Agency IQ

SEPTEMBER 15, 2023

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.

Regulations 40

Regulations Packaging Production Organic Chemistry 40

Agency IQ

MARCH 1, 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. Consultations are held to allow interested parties to contribute to this process.

Regulations 40

Regulations Production Packaging Science 40

Agency IQ

MAY 31, 2024

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).

Regulations 40

Regulations Production International Government 40

Drug Target Review

DECEMBER 5, 2024

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.

Therapies 52

Therapies Virus DNA Compliance 52

Agency IQ

FEBRUARY 23, 2024

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.

Packaging 40

Packaging Regulations Production Compliance 40

Advarra

JUNE 6, 2022

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.

Compliance 52

Compliance Production Clinical Trials Packaging 52

Agency IQ

AUGUST 2, 2024

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).

Regulations 40

Regulations Production Packaging International 40

Agency IQ

AUGUST 30, 2024

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).

Regulations 40

Regulations Production Government Packaging 40

Agency IQ

OCTOBER 27, 2023

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).

Regulations 40

Regulations Production Packaging International 40

Agency IQ

MAY 3, 2024

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 (..)

FDA 40

FDA Science Regulations Clinical Trials 40

Agency IQ

JANUARY 4, 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).

Regulations 40

Regulations Packaging Production Government 40

Agency IQ

SEPTEMBER 29, 2023

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.

Regulations 40

Regulations Packaging Production International 40

Agency IQ

DECEMBER 1, 2023

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).

Regulations 40

Regulations Production International Marketing 40

Agency IQ

FEBRUARY 2, 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).

Regulations 40

Regulations Production Government Marketing 40

Agency IQ

JULY 8, 2024

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 (..)

FDA 40

FDA Science Regulations Production 40

Agency IQ

APRIL 12, 2024

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.

Production 40

Production FDA Therapies Biochemical Assays 40

Agency IQ

OCTOBER 27, 2023

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.

FDA 40

FDA Science Regulations Production 40

Agency IQ

AUGUST 2, 2024

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: (..)

FDA 40

FDA Science Regulations Biosimilars 40

Agency IQ

AUGUST 23, 2024

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, (..)

Science 40

Science FDA Marketing Production 40

Agency IQ

MARCH 29, 2024

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.

Regulations 40

Regulations Compliance Production Government 40

Agency IQ

DECEMBER 1, 2023

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.

Regulations 40

Regulations Production Compliance Science 40

The Pharma Data

MAY 13, 2021

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.

Production 52

Production Treatment Vaccine Therapies 52

Agency IQ

OCTOBER 27, 2023

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 (..)

Regulations 40

Regulations Compliance Science Production 40

Agency IQ

DECEMBER 15, 2023

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.

Regulations 40

Regulations Compliance Production Government 40

Agency IQ

DECEMBER 1, 2023

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.

FDA 40

FDA Science Regulations Production 40

Agency IQ

FEBRUARY 2, 2024

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.

Regulations 40

Regulations Compliance Engineering Government 40

Agency IQ

JANUARY 4, 2024

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.

Regulations 40

Regulations Compliance Government Science 40