Packaging, Pharmaceuticals and Webinar

New Solutions for Aseptic Filling for Gene Therapy

Fierce BioTech

MAY 2, 2024

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. In this webinar, you will learn about: The challenges and risks related to the packaging and filling of high-value drug products.

Therapies

Therapies Packaging Pharmaceuticals Production

Developing and Manufacturing Minitablets to Extend Drug Lifecycle

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.

Drugs

Drugs Packaging Compliance Drug Development

Article Periodic Thank You Commission unveils “one substance, one assessment” reform package

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. Data from pharmaceutical legislation is not included by default, though some specifically named pharma data relating to chemicals will be encompassed.

Packaging

Packaging Regulations Laboratories Animal Testing

Cost-Effective Sterilization Method

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

Packaging FDA Production Drug Development

Article EMA Thank You What we expect European regulators to do in November 2023

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

Regulations Pharmaceuticals Production Packaging

Article EMA Thank You What we expect European regulators to do in June 2024

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

Regulations Production Compliance Pharmaceuticals

Article EMA Thank You What we expect European regulators to do in May 2024

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. voted to adopt the compromise texts of both the revised pharmaceutical directive and regulation presented by Parliament’s health committee in March 2024. On April 10, the E.U. On April 10, the E.U.

Regulations

Regulations Clinical Trials Production Biosimilars

Article EMA Thank You What we expect European regulators to do in August and September 2024

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

Regulations Clinical Trials Production Trials

Q&A: The IND Journey Phase I – Navigating Success

Advarra

JULY 19, 2022

Advarra experts Sharon Ayd and Leslie Paul answer questions from their webinar, The IND Journey Phase I – Navigating Success. The sponsor is the pharmaceutical company conducting the trial. A: Working in a pharmaceutical company is the best way to learn this. A: Yes, the EUA is just temporary. A: This does not usually happen.

Packaging

Packaging FDA Trials Regulations

New insights into the role of viral capsids in gene therapy safety

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

Therapies Virus DNA Compliance

Analysis Life Sciences Thank You What We Expect the FDA to do in May and June 2024

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

FDA Science Regulations Clinical Trials

Analysis Life Sciences Thank You What We Expect the FDA to do in July and August 2024

Agency IQ

JULY 8, 2024

Letter Program Tag Commitment Due Date PDUFA Advancing RWE Program Report containing aggregated and anonymized information describing RWE submissions to CDER and CBER. and the E.C.

FDA

FDA Science Regulations Production

Article FDA Thank You Draft guidance on potency assays for CGT products garners extensive stakeholder input

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. The Pharmaceutical Research and Manufacturers of America (PhRMA) also voiced this concern, asking the FDA to provide “additional detail regarding phase appropriate implementation.”

Production

Production FDA Therapies Biochemical Assays

Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

Agency IQ

OCTOBER 27, 2023

WUSF / AgencyIQ November 1 Initial deadline for NDSRIs Under a 2023 guidance document, the FDA has recommended that pharmaceutical companies assess Nitrosamine Drug-Related Substance Impurities for their products by November 1, 2023, with confirmatory testing due by August 1, 2025.

FDA

FDA Science Regulations Production

Analysis Life Sciences Thank You What We Expect the FDA to do in August and September 2024

Agency IQ

AUGUST 2, 2024

and the E.C.

FDA

FDA Science Regulations Biosimilars

Analysis Chemical Thank You The 174 regulations the EPA is currently working on

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

Regulations Compliance Production Government

Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

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

FDA Science Regulations Production

Analysis Chemical Thank You What we expect the EPA to do in January 2024

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

Regulations Compliance Government Science

Drug Discovery Digest

New Solutions for Aseptic Filling for Gene Therapy

Developing and Manufacturing Minitablets to Extend Drug Lifecycle

Trending Sources

Article Periodic Thank You Commission unveils “one substance, one assessment” reform package

Cost-Effective Sterilization Method

Article EMA Thank You What we expect European regulators to do in November 2023

Article EMA Thank You What we expect European regulators to do in June 2024

Article EMA Thank You What we expect European regulators to do in May 2024

Article EMA Thank You What we expect European regulators to do in August and September 2024

Q&A: The IND Journey Phase I – Navigating Success

New insights into the role of viral capsids in gene therapy safety

Analysis Life Sciences Thank You What We Expect the FDA to do in May and June 2024

Analysis Life Sciences Thank You What We Expect the FDA to do in July and August 2024

Article FDA Thank You Draft guidance on potency assays for CGT products garners extensive stakeholder input

Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

Analysis Life Sciences Thank You What We Expect the FDA to do in August and September 2024

Analysis Chemical Thank You The 174 regulations the EPA is currently working on

Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

Analysis Chemical Thank You What we expect the EPA to do in January 2024

Stay Connected