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12 02, 2015

1-3 June, 2015: PDA Europe Conference – Amsterdam, The Netherlands

By | February 12th, 2015|Project|0 Comments

On 2-3 June 2015 Amsterdam will host the 2015 PDA Europe Advanced Therapy Medicinal Products Conference. In cooperation with the AGORA project, PDA Europe offers on 1 June a pre-conference [...]

12 02, 2015

MHRA Review of Deficiencies Observed during GMP Inspection in 2013

By | February 12th, 2015|Publications|0 Comments

During 2013 the MHRA performed 174 inspections in the UK and 42 overseas. The top 5 categories where the most defects were observed are: • Investigation in anomalies • Quality [...]

4 02, 2015

New publication about CMV-CTL manufacturing as an ATMP

By | February 4th, 2015|Publications|0 Comments

A new publication about CMV-CTL manufacturing as an ATMP has been pusblished. Prof Dr. Ulrike Köhl (AGORA)  is one of the authors. Tischer S, Priesner C, Heuft HG, Goudeva L, [...]

13 01, 2015

Topic of the month

By | January 13th, 2015|Topic of the Month|0 Comments

Release of IMPs: How do you perform the dual release by a Qualified Person and the Sponsor in accordance with Annex 13?  

11 11, 2014

AGORA Newsletter 3, November 2014

By | November 11th, 2014|Project|0 Comments

Here is the third edition of the AGORA project Newsletter, November 2014:   Agora Newsletter November 14

3 11, 2014

Draft: Functional specifications for the EU portal and EU database to be audited published for comments

By | November 3rd, 2014|News|0 Comments

One of the main features of the Clinical Trials Regulation (CTR) EU No 536/2014 repealing the Clinical Trials Directive is the creation of the EU portal and the EU database [...]

2 11, 2014

Revised GMP chapters published

By | November 2nd, 2014|News|0 Comments

The EC has published several revised chapters of the EU guidelines for GMP in August, minor changes were made in chapters 3 (Premises and Equipment) and 5 (Production). Chapter 8 [...]

2 11, 2014

AGORA’s regulatory survey  data presented

By | November 2nd, 2014|Project, Survey|0 Comments

The regulatory survey on the impact and vision of GMP facilities that has been performed from June to September has been finalized. A total of 55 facilities over 13 countries [...]

30 10, 2014

Presentations of the CAT-DGTI-GSCN Workshop on Advanced Therapy Medicinal Products (Dresden 11 Sept 2014)

By | October 30th, 2014|News|0 Comments

All workshop's presentation were published on the EMA Website. To review them please use the following link: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/events/2014/05/event_detail_000941.jsp&mid=WC0b01ac058004d5c3  

30 10, 2014

European Regional Meeting

By | October 30th, 2014|News, Upcoming events|0 Comments

Mark your Calendar: In September 2015, probably from Sept 24 until September 27, a European regional meeting will take place in Seville, Spain. More details will be available soon at: [...]