About Jill

Jillian Glancey | Marketing Executive
10 05, 2023

The Importance of GDP in Radiopharma

By |2023-05-10T12:42:11+01:00May 10th, 2023|Featured, Technical Article|

GDP (Good Distribution Practice) is essential in Radiopharma Clinical Trials because it ensures that the medicinal products being used are of consistent quality and are delivered to the clinical trial site in a safe and secure manner. GDP guidelines are designed to ensure that all aspects of the clinical trial supply chain, from manufacturing

9 05, 2023

Practical considerations for QP release of Radiopharmaceutical clinical trials into Europe

By |2023-05-09T15:16:21+01:00May 9th, 2023|Featured, Technical Article|

Radiopharmaceuticals are used in the specialised area of nuclear medicine (clinical imaging and therapy) to diagnose, evaluate and treat diseases. The use of radiopharmaceuticals covers a broad range of procedures such as: diagnosis (single photon emission computed tomography, SPECT; and positron emission tomography, PET) radiation therapy (for oncology and palliative pain management) early research

25 04, 2023

What does a Pharma company need to do to become Annex 1 compliant and how could MIAS Pharma Ltd help

By |2023-04-26T14:00:42+01:00April 25th, 2023|Featured, Technical Article|

Annex 1 of the European Union's Good Manufacturing Practice (GMP) guidelines sets out the requirements for the manufacture of sterile medicinal products. To become Annex 1 compliant, a pharma company needs to ensure that its manufacturing processes and facilities meet the standards outlined in the guideline. The following are some of the key requirements

24 02, 2022

Brexit and the Evolving Impact on the Pharmaceutical World

By |2022-05-10T13:36:23+01:00February 24th, 2022|Featured, Technical Article|

Brexit took place at 11pm on 31 Jan 2020 as the UK departed from the European Union. A transition period of 11 months began on 01 Feb 2020 until 31 Dec 2020. This transition period allowed for the UK to continue to follow EU rules while both sides worked out what the future EU/UK

2 02, 2022

New QTA requirements with Importation Site

By |2023-03-14T14:36:57+00:00February 2nd, 2022|Featured, Technical Article|

The manufacture of pharmaceutical products for the EU, including active substances and medicinal products, frequently occurs outside of the Union. As required by the HPRA “A manufacturer’s authorisation (MIA) is needed if a company is involved in any of the following manufacturing activities:  processing of a dosage form, primary packaging, secondary packaging, batch certification,

22 12, 2021

EMA Reflection Paper on GMP & MAHs – considerations for QPs

By |2023-03-14T14:31:05+00:00December 22nd, 2021|Featured, Technical Article|

In July 2021, the European Medicines Agency (EMA) published the final reflection paper entitled "Good Manufacturing Practice and the Marketing Authorisation Holder" after a period of consultation with the relevant stakeholders. The document focuses on and describes the good manufacturing practice (GMP) responsibilities applicable to Marketing Authorisation Holders (MAHs). With the rise in virtual

15 12, 2021

Merry Christmas and Happy New Year

By |2021-12-15T16:24:54+00:00December 15th, 2021|Featured, General News|

MIAS has continued exceptional growth and development over 2021. We'd like to thank our Team, Customers and Suppliers for contributing to the continued success of MIAS. We would like to wish you all a very Merry Christmas and we look forward to what will come in 2022. Our offices will close on Friday 24th

28 10, 2021

Good Practices for Data Management and Integrity

By |2021-11-08T13:49:48+00:00October 28th, 2021|Featured, Technical Article|

The pharmaceutical industry is underpinned by a large amount of documentation to show evidence of the quality, safety and efficacy of the drug product throughout it's life cycle. The integrity of records and data can be breached at any time, by any employee – either intentionally or unintentionally.  Data integrity failure may involve omissions,

23 09, 2021

QP Declarations – Key Considerations

By |2023-03-14T14:20:34+00:00September 23rd, 2021|Featured, Technical Article|

So are you preparing and filing a Marketing Authorisation Application (MAA) in Europe? What needs to be considered and what timelines do you need to work towards? Active Pharmaceutical Ingredients or APIs must be manufactured in compliance with EU GMP and this compliance is confirmed by the QP declaration, which is submitted with the

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