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

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. Posted 04 May 2021 | By Joanne S. Eglovitch

Production

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Webinars

Bridging Innovation & Patient Care: The Growing Role of AI

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Some Thoughts on Biotech vs Pharma for Computational Chemists

Practical Cheminformatics

DECEMBER 7, 2023

The Medicinal Chemistry Gordon Research Seminar ( GRS ) provides a condensed version of ResMed. On two separate occasions, VP-level medicinal chemists from large pharmaceutical companies told me, “We have a solubility model that is so good, we stopped running the assay.” Find mentors from other disciplines who can help you learn.

Computational Chemistry

Computational Chemistry Pharmacokinetics Drugs Pharmaceutical Companies

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

Drug Target Review

DECEMBER 5, 2024

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. 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

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.:

Regulations

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

Regulations Production Clinical Trials Biosimilars

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

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

Agency IQ

AUGUST 2, 2024

Positive August 2024 Eurneffy (epinephrine) Ars Pharmaceuticals Irl Limited Positive August 2024 MResvia (Respiratory Syncytial Virus mRNA vaccine) Moderna Biotech Spain S.L. Positive August 2024 Balversa (erdafitinib) Janssen-Cilag International N.V.

Regulations

Regulations Clinical Trials Production Trials

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). As AgencyIQ has previously discussed , developing biosimilars is an expensive process.

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. 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).

Regulations

Regulations Pharmaceuticals Production Vaccine

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

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

Agency IQ

DECEMBER 1, 2023

and Annex 1 Conference Joel Welch December 12 AgencyIQ Looking ahead to 2024: Regulatory Forecast for the U.S. The guidance will include FDORA, Section recommendations FDORA, Section on the inclusion of the “the longest feasible expiration date supported by such data” in a drug’s label.

FDA

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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

Webinars

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

Webinars

Some Thoughts on Biotech vs Pharma for Computational Chemists

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

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

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

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

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

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