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

Agency IQ

MAY 3, 2024

Two consultations on clinical trial considerations, one on advanced therapies and the other addressing non-inferiority and equivalence comparisons, are closing at the end of May. voted to adopt the compromise texts of both the revised pharmaceutical directive and regulation presented by Parliament’s health committee in March 2024.

Regulations

Regulations Clinical Trials Production Biosimilars

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

Drug Target Review

DECEMBER 5, 2024

The large number of ongoing clinical trials of recombinant AAV (rAAV)-based therapies highlights their promise for addressing a wide variety of human genetic disorders. She is a recognised expert in chromatography and protein purification, and serves as a regular panellist at conferences, seminars, and webinars.

Therapies

Therapies Virus DNA Compliance

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Webinars

Bridging Innovation & Patient Care: The Growing Role of AI

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

Agency IQ

MARCH 1, 2024

There are also some product-specific bioequivalence guidelines open for comment, along with concept papers proposing the development of materials on the topics of biosimilar development and non-inferiority comparisons in clinical trials.

Regulations

Regulations Biosimilars Clinical Trials Production

Webinars

Bridging Innovation & Patient Care: The Growing Role of AI

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

Agency IQ

MARCH 29, 2024

Perhaps the most significant pharmaceutical news anticipated for April: the vote on the pharmaceutical legislation revision. regulatory framework Webinar/ Seminar ( OPEN ) EMA 4/17/2024 4/17/2024 CEP 2.0: regulatory framework Webinar/ Seminar ( OPEN ) EMA 4/17/2024 4/17/2024 CEP 2.0:

Regulations

Regulations Production Clinical Trials Biosimilars

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

Agency IQ

MAY 31, 2024

Start Date End Date Event Event Type Organization 6/03/2024 6/03/2024 Product Management Service (PMS) Product UI and API training (access & navigation) Webinar/Seminar ( OPEN ) EMA 6/03/2024 6/07/2024 Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the E.U.:

Regulations

Regulations Production Compliance Pharmaceuticals

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

Agency IQ

AUGUST 2, 2024

While the work on the pharma package will likely take quite some time, another deadline is coming up fast: the full transition of all clinical trials from the Clinical Trials Directive to the Clinical Trials Regulation.

Regulations

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

Agency IQ

OCTOBER 27, 2023

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

Analysis Life Sciences Thank You FDA fiscal year in review: New drug approvals in the wake of the pandemic and legislative reforms

Agency IQ

OCTOBER 6, 2023

CDER is the FDA office in charge of reviewing pharmaceuticals and therapeutic biologics. All products are received in one of two forms: A New Drug Application (or NDA, for pharmaceuticals) or a Biologics License Application (BLA, for biologics). The trend of incorporating clinical trial diversity into PMRs continued in FY 2023.

FDA

FDA Biosimilars Science Drugs

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

Agency IQ

JULY 8, 2024

The European Council held its first public debate of the proposed pharmaceutical legislation last week. Device regulators have dropped important guidance recently , publishing guidance on alternative trial designs for orphan devices and updating how to carry out benefit-risk assessments on the use of toxic phthalates in medical devices.

Regulations

Regulations Pharmaceuticals Production Vaccine

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

Agency IQ

DECEMBER 1, 2023

12/29/2023 FDORA, Section 3602 Clinical Trials Modernization : FDA is directed to require the submission of a “diversity action plan” for all Phase 3 clinical trials of new drugs. .” ” These include the use of expansion cohorts, concurrent trial conduct, and other designs. .”

FDA

FDA Science Regulations Production

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

Agency IQ

DECEMBER 1, 2023

Start Date End Date Event Event Type Organization 12/01/2023 12/01/2023 BIVDA Environmental Working Party Webinar/Seminar ( CLOSED ) British In Vitro Diagnostics Association (BIVDA) 12/04/2023 12/04/2023 HMA/EMA Big Data Stakeholder Forum 2023 Webinar/Seminar ( OPEN ) European Medicines Agency (EMA) / Heads of Medicines Agencies (HMA) 12/04/2023 12/04/2023 (..)

Regulations

Regulations Clinical Trials Production Biosimilars

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Drug & Device Law

APRIL 16, 2023

DRI’s Drug and Medical Device Committee will hold its annual Seminar on May 3-5, 2023 , at the Hilton New Orleans Riverside, in New Orleans, Louisiana. The Seminar is a preeminent program for practitioners who represent pharmaceutical and medical device manufacturers.

FDA Approval

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

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

Webinars

Trending Sources

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

Webinars

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

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 August and September 2024

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

Analysis Life Sciences Thank You FDA fiscal year in review: New drug approvals in the wake of the pandemic and legislative reforms

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

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

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

Guest Shameless Plug

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