Drugs, Pharmaceuticals and Seminar - Drug Discovery Digest

“Thaw Out” with Pharma Thought Leaders at the 2024 Puerto Rico Pharmaceutical Summit: HPM Directors to Discuss Drug Approvals and Puerto Rico “Exportation” Best Practices

FDA Law Blog: Biosimilars

JANUARY 11, 2024

(HPM) Directors, Karla Palmer and Dara Levy , will present at the Puerto Rico Pharmaceutical Summit 2024, February 6, 2024, at the La Concha Renaissance San Juan Resort in San Juan, Puerto Rico.

Pharmaceuticals

Pharmaceuticals Licensing Licensing Compliance

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

Agency IQ

MAY 3, 2024

voted to adopt the compromise texts of both the revised pharmaceutical directive and regulation presented by Parliament’s health committee in March 2024. Start Date End Date Event Event Type Organization 4/30/2024 4/30/2024 Seminar No. Start Date End Date Event Event Type Organization 4/30/2024 4/30/2024 Seminar No.

Regulations

Regulations Clinical Trials Production Biosimilars

Some Thoughts on Biotech vs Pharma for Computational Chemists

Practical Cheminformatics

DECEMBER 7, 2023

A recent editorial by Dean Brown in J Med Chem and follow-up posts by Keith Hornberger and Derek Lowe prompted me to think about how we train computational chemists and cheminformaticians for careers in drug discovery. When someone joins a drug discovery company from academia, they are often paired with more experienced colleagues.

Computational Chemistry

Computational Chemistry Pharmacokinetics Drugs Pharmaceutical Companies

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Bridging Innovation & Patient Care: The Growing Role of AI

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Supply chain members concerned over sluggish testing of data systems under DSCSA

The Pharma Data

MAY 4, 2021

In a recent traceability forum, the pharmaceutical industry and other trading partners were told to start testing their data systems now to ensure that any glitches are ironed out before prescription drug products must be electronically tracked through the supply chain to ward off counterfeiting. Eglovitch . Source link.

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

Drug Target Review

DECEMBER 5, 2024

1 In 2017, the US Food and Drug Administration (FDA) approved the first AAV-based gene replacement therapy (Luxturna), for Leber congenital amaurosis type 2. In this role, she works with leaders in the biotech and pharmaceutical industries to understand how Bio-Rad can accelerate drug discovery and development in new therapeutic areas.

Therapies

Therapies Virus DNA Compliance

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

Agency IQ

MARCH 1, 2024

European Parliament negotiations on the proposed regulation and directive to overhaul the pharmaceutical legislation are ongoing. Although our POLITICO Pro EU colleagues have provided some updates, the discussions are held behind closed doors.

Regulations

Regulations Biosimilars Clinical Trials Production

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.:

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Regulations Production Compliance Pharmaceuticals

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

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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

FDA fiscal year in review: New drug approvals in the wake of the pandemic and legislative reforms AgencyIQ analyzed CDER’s novel drug approvals in Fiscal Year 2023, identifying a recovery in approval numbers as the agency resumes a new normal following the pandemic. As a reminder, the U.S.

FDA

FDA Biosimilars Science Drugs

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

Agency IQ

AUGUST 2, 2024

Start Date End Date Event Event Type Organization 8/5/2024 8/8/2024 PRAC August meeting Committee Meeting ( CLOSED ) Pharmacovigilance Risk Assessment Committee (PRAC) 8/6/2024 8/6/2024 Infectious Diseases Working Party Seminar ( CLOSED ) British In Vitro Diagnostics Association (BIVDA) 08/12/2024 5 weeks Explore innovative personalized therapeutic (..)

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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. There will also be a rescheduled webinar held at the end of the month to go over the Artificial Intelligence Airlock initiative spearheaded by the U.K.’s ’s Medicines and Healthcare products Regulatory Agency (MHRA).

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

Agency IQ

DECEMBER 1, 2023

December also has a huge number of legislative deadlines associated with the Food and Drug Omnibus Reform Act of 2022. Drug Importation: We may soon receive greater clarity about the FDA’s thinking about prescription drug importation plans. December also typically brings end-of-year perspectives on the agency’s accomplishments.

FDA

FDA Science Regulations Production

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

Agency IQ

DECEMBER 1, 2023

The European Commission also plans to create a Critical Medicines Alliance for a more coordinated effort in managing drug shortages within the E.U. We are expecting to see the release of an E.U. This effort will most likely be set up in early Q1 of 2024.

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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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Drug Discovery Digest

“Thaw Out” with Pharma Thought Leaders at the 2024 Puerto Rico Pharmaceutical Summit: HPM Directors to Discuss Drug Approvals and Puerto Rico “Exportation” Best Practices

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

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Some Thoughts on Biotech vs Pharma for Computational Chemists

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Supply chain members concerned over sluggish testing of data systems under DSCSA

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

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

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

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