GMP News - Pharmaceutical Development / Clinical Trials / GCP

19.12.18

New Ph. Eur Monograph on PAT adopted

The European Pharmacopoeia (Ph. Eur.) Commission adopted 16 new texts including the general chapter on PAT - Process analytical technology (5.25).

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18.12.18

Gene Therapeutics - FDA updates Requirements for CMC Information

In recent months, the FDA has published a number of documents on gene therapy. With a draft guideline on "Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)", the next step in the update of the relevant guidelines has been taken.

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06.12.18

New ICH Topic M11 CeSHarP

A new ICH topic was endorsed by the ICH Management Committee in November 2018. Read more about the proposed new ICH M11 guideline Clinical electronic Structured Harmonized Protocol (CeSHarP).

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06.12.18

FDA allows greater flexibility for clinical investigators about informed consent

The FDA proposes to allow greater flexibility for clinical investigators about informed consent in minimal risk situations. Read more about Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations.

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06.12.18

Dose Escalation - is it GCP compliant?

On the MHRA Inspectorate blog a new post has just been published emphasizing that according to GCP dose escalation practices should be the same regardless of whether a clinical trial involves healthy volunteers or patients. Read more about "Dose Escalation - is it GCP compliant?"

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03.12.18

New ICH Topic Q14 and Revision of Q2

A new ICH topic was endorsed by the ICH Management Committee in November 2018. Read more about the proposed new ICH Q14 guideline Analytical Procedure Development and the revision of Q2(R1) Analytical Validation.

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15.11.18

MHRA & FDA: First Joint Workshop on GCP in Washington

Data integrity plays an exceptional role in clinical studies. On 23-24 October, 2018, the US FDA and the British MHRA hosted a joint workshop on this topic. Learn more about the contents and results of the joint workshop "Good Clinical Practice: Data Integrity in Global Clinical Trials - Are we there yet?"

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15.11.18

Stability by Design - Guidelines for Assessing & Controlling Physical Stability

The USP Physical Stability Joint Subcommittee has published a Stimuli article regarding Guidelines For Assessing and Controlling the Physical Stability of Pharmaceutical Raw Materials, Intermediates, and Dosage Forms. 

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14.11.18

USP article on pharmaceutical continuous manufacturing

In the latest edition of the Pharmacopoeial Forum 44(6), the US pharmacopoeia USP has published a so-called Stimuli Article on pharmaceutical continuous manufacturing. Apart from important definitions, the document contains further information on material properties and characteristics as well as risk management approaches for continuous manufacturing.

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08.11.18

Products with Genetically modified Cells - Draft Guideline

Due to the ongoing scientific development of laboratory methods, the EMA published a draft revision of their "Guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells" for public consultation.

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08.11.18

False Positive HTLV Testing - Recommendations for Donor Requalification

In October 2018, the FDA published a new draft guidance with recommendations for a possible requalification of donors who had been deferred because of reactive test results for antibodies to Human T-Lymphotropic Virus Types I and II (anti-HTLV-I/II). Read more about the requalification method under 21 CFR 610.41.

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18.10.18

Sponsor Oversight - Metrics & Case Studies

The overall responsibility for clinical trials lies with the sponsor. Whereas activities may be contracted or delegated, responsibility itself can not. Read more about metrics and case studies from GCP inspections with regard to sponsor oversight of clinical trials.

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18.10.18

What is required for electronic informed consent (eConsent)?

The MHRA released a joint statement setting out the legal and ethical requirements for documenting consent using electronic methods. Read more about the MHRA´s view of seeking consent electronically (eConsent).

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16.10.18

Revision: FDA Guideline on Adaptive Designs for Clinical Trials

In September, the US Food and Drug Administartion published a draft guidance on Adaptive Designs for Clinical Trials of Drugs and Biologics. It is the revision of the existing guidance from 2010.

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16.10.18

FDA Guidance on Efficient Clinical Trial Design Strategies for Cancer Drugs and Biologics

Relating to the increasing need of simultaneously evaluatation of more than one investigational drug and/or more than one cancer type in one clinical trial, the FDA published a new guidance on Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics.

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