19 09, 2022

Reminder: 4 days to BREXIT Event!

By |2022-09-19T16:18:13+00:00September 19th, 2022|Featured, General Events, General News|

Our CEO Ann McGee will be speaking at the Pharma and Brexit Conference - hosted by PDA Ireland and PDA United Kingdom. The event will focus on the impact, challenges and solutions for the pharmaceutical industry. Register now on Eventbrite: https://lnkd.in/eVxTutkC Date - September 23rd, 2022 Venue - Crowne Plaza Hotel, Dublin Airport Time - 8:00 a.m. -

14 09, 2022

MIAS Pharma Welcomes New CEO Pierre-Henri Baviera

By |2022-09-14T08:59:17+00:00September 14th, 2022|Featured, General Events, General News|

We are very excited to announce the appointment of Pierre-HenriBaviera as the new CEO for Mias Pharma Limited.  As an experienced CEO, Pierre brings significant senior international leadership capabilities in Professional Services and Technology companies. He will be focused on the next phase of growth for MIAS's people and customers in line with our

17 08, 2022

Upcoming Shows

By |2022-08-17T13:42:55+00:00August 17th, 2022|Featured, General Events, General News|

MIAS Pharma will be attending the following events in the coming months: 35th Annual Congress of the European Association of Nuclear Medicine (EANM), Barcelona, 15th - 19th of October 2022. The EANM’s vision is to optimise and advance science and education in nuclear medicine for the benefit of public health and humanity within the

15 08, 2022

Annex 21 in Effect from August 21st 2022

By |2022-08-22T09:07:54+00:00August 15th, 2022|Featured, Industry News, News|

The new Annex 21, The Rules Governing Medicinal Products in the European Union Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use, is now in effect. Are you prepared for it's changes? There are a number of key requirements for a Manufacturing Import Authorisation (MIA) holder when

9 08, 2022

BREXIT – Impact, Challenges and Solutions for the Pharmaceutical Industry

By |2022-08-21T21:20:01+00:00August 9th, 2022|Events, Featured, General Events|

Our CEO Ann McGee will be speaking at the Pharma and Brexit Conference - hosted by PDA Ireland and PDA United Kingdom. The event will focus on the impact, challenges and solutions for the pharmaceutical industry. Date - September 23rd, 2022 Venue - Crowne Plaza Hotel, Dublin Airport Time - 8:00 a.m. - 5:00 p.m. Please see below

27 07, 2022

The Commenting Process for new GDP-relevant Documents from FDA and USP has been extended.

By |2022-07-27T11:31:00+00:00July 27th, 2022|Featured, General News, Industry News|

FDA Proposed Rule "National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers" In February 2022, the FDA has announced the availability of the proposed rule "National Standards for the Licensure of Wholesale Drug Distributors (WDDs) and Third-Party Logistics Providers (3PLs)". The proposed rule sets national licensing standards for both federal and

13 04, 2022

GMP/GDP Audits & the Importance of CAPA

By |2022-05-10T13:22:37+00:00April 13th, 2022|Featured, Technical Article|

The conduct of audits is a key part of our Pharmaceutical Quality Systems to give us information on the activities and standards to which our suppliers and contractors operate. It is important for us to have confidence in the quality of the materials and products that are manufactured and analysed and in control of

24 02, 2022

Brexit and the Evolving Impact on the Pharmaceutical World

By |2022-05-10T13:36:23+00:00February 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 |2022-05-10T13:46:02+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 |2021-12-22T16:07:09+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

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