Drug Discovery World

NOVEMBER 23, 2022

In addition, the integration of process development, manufacturing, packaging, and supply logistics of pDNA are critical to improving access and reducing timelines as this brings life-changing therapies to the patient sooner. Building a robust supply of GMP-grade pDNA requires that quality be a focal point of the production process.

DNA 130

DNA Packaging Therapies Vaccine 130

Drug Discovery World

JULY 5, 2023

This webinar will help you understand the AAV workflow, from upstream methods for AAV production and validation to downstream analysis of the packaged product for enhanced therapeutic development. AAV is optimal for gene therapy due to its efficiency and safety in humans; however, AAV processes can present obstacles for researchers.

Virus 130

Virus Therapies Bioinformatics Packaging 130

Drug Discovery World

JUNE 29, 2023

This webinar will help you understand the AAV workflow, from upstream methods for AAV production and validation to downstream analysis of the packaged product for enhanced therapeutic development. AAV is optimal for gene therapy due to its efficiency and safety in humans; however, AAV processes can present obstacles for researchers.

Virus 130

Virus Therapies Bioinformatics Packaging 130

Drug Discovery World

JUNE 22, 2023

This webinar will help you understand the AAV workflow, from upstream methods for AAV production and validation to downstream analysis of the packaged product for enhanced therapeutic development. AAV is optimal for gene therapy due to its efficiency and safety in humans; however, AAV processes can present obstacles for researchers.

Virus 130

Virus Therapies Bioinformatics Packaging 130

Drug Discovery World

JULY 25, 2023

In this webinar, sponsored by Elegen, attendees learnt about the breakthroughs in mRNA drug discovery and development. Second, our formulation is more tightly packaged compared with the industry standard as we only require 50% of the lipids. DDW recently hosted Where are the breakthroughs in mRNA drug discovery and development?

Packaging 130

Packaging Drugs Licensing Licensing 130

Agency IQ

JANUARY 19, 2024

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.

Packaging 40

Packaging Regulations Laboratories Animal Testing 40

Drug Discovery World

JUNE 23, 2023

A guide to using adeno-associated virus (AAV) vectors in gene therapy This webinar will help you understand the AAV workflow, from upstream methods for AAV production and validation to downstream analysis of the packaged product for enhanced therapeutic development.

FDA Approval 130

FDA Approval Therapies Packaging Drugs 130

Fierce BioTech

MAY 2, 2024

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.

Therapies 52

Therapies Packaging Pharmaceuticals Production 52

Fierce BioTech

JANUARY 12, 2024

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.

Packaging 52

Packaging Compliance Drugs Drug Development 52

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

Alta Sciences

AUGUST 15, 2023

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.

Packaging 40

Packaging FDA Production 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

OCTOBER 27, 2023

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?

Regulations 40

Regulations Pharmaceuticals Production Packaging 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

Drug Discovery World

MARCH 29, 2023

What is likely to be the cumulative effect on innovation of the different losses in exclusivity, also given the forthcoming Patent Package which could link the review’s rules on product shortages to EU-wide compulsory licensing? You can compare timelines. I would claim that the variety offered here is on a par with other regions.”

Clinical Trials 130

Clinical Trials Biosimilars Pharma Companies Production 130

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

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

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

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

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 Regulations Trials 52

Drug Discovery World

FEBRUARY 6, 2023

This approach has led to the development of two software packages for RNA sequencing analysis and reproducible ribosomal profiling 1,2. We also developed an R package to determine optimal gene filtering cut offs and modeled statistical power to detect DE genes for a range of sample sizes, effect sizes, and coverage depths 3.

Bioinformatics 130

Bioinformatics RNA Vaccine Clinical Trials 130

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 Research 52

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

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

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

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

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

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 Packaging 97

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 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

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 Packaging Clinical Trials 52

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

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

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

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