'Marketing authorisation' presentation slideshows

Training Workshop on Pharmaceutical Development with focus on Paediatric Formulations Protea Hotel

Pharmaceutical Development. Training Workshop on Pharmaceutical Development with focus on Paediatric Formulations Protea Hotel Victoria Junction, Waterfront Cape Town, South Africa Date: 16 to 20 April 2007. Introduction to the WHO Prequalification programme and Regulatory aspects.

854 views • 51 slides

Training Workshop on Pharmaceutical Development with focus on Paediatric Formulations Protea Hotel

Pharmaceutical Development. Training Workshop on Pharmaceutical Development with focus on Paediatric Formulations Protea Hotel Victoria Junction, Waterfront Cape Town, South Africa Date: 16 to 20 April 2007. Introduction to the WHO Prequalification programme and Regulatory aspects.

629 views • 51 slides

Training on basic aspect of Good Manufacturing Practices (GMP)

973 views • 49 slides

Training on basic aspect of Good Manufacturing Practices (GMP)

714 views • 49 slides

Thursday, 13 October 2005 Parallel Session The APIC Audit Programme presented by Dr Tom Buggy, DSM-Anti-Infectives B.V.,

744 views • 46 slides

EMEA European Medicines Agency

EMEA European Medicines Agency. Presented by: Aarohi Shah M. Pharm: L.M.C.P. Department of Pharmaceutics and Pharmaceutical Technology. Structure. The EMEA began its activities in 1995. Decentralised body of the European Union - headquarters in London.

1.5k views • 44 slides

Objectives/Agenda

Overview of the Role of the Regulatory Agencies and of Regulations in Product Development for Pharma Remit of EMA/FDA. Objectives/Agenda. The role of regulation History of regulation Control points Control of clinical trials NDA/MAA submission Comparison of pharma and device controls.

465 views • 36 slides

From Bottlenecks to Solutions: Clinical Trials

R x. D. From Bottlenecks to Solutions: Clinical Trials. Brendan M Buckley European Centre for Clinical Trials in Rare Diseases University College Cork National University of Ireland. Orphan Medicines: Concept. Orphan medicines are for Prevention, treatment or diagnosis, of

398 views • 26 slides

The Paediatric Regulation

The Paediatric Regulation. Paediatric Team Scientific Advice, Paediatrics & Orphan Drugs Sector EMEA 2007. The current situation. 20 % of the EU population, i.e. 100 million, is aged less than 16 years ? premature neonate, term neonate, infant, child, adolescent

537 views • 24 slides

361 views • 24 slides

The Paediatric Regulation

The Paediatric Regulation. Paediatric Team Scientific Advice, Paediatrics & Orphan Drugs Sector EMEA 2007. The current situation. 20 % of the EU population, i.e. 100 million, is aged less than 16 years ? premature neonate, term neonate, infant, child, adolescent

525 views • 24 slides

PAGB Medicines Advertising Codes Amendments to the Code May 2011

372 views • 22 slides

EU publicly funded research programs

EU publicly funded research programs. FDA/EMA Orphan Designation and Grant Workshop (12 Oct 2012). Presented by: Jordi Llinares Head of orphan medicines. Outline. Small and Medium sized Enterprises at EMA The European Framework programme A collaborative example.

358 views • 22 slides

Registration and Harmonisation in the Area of Medical Products in Switzerland

533 views • 19 slides

>70

316 views • 19 slides

7th EGA Legal Affairs Forum

272 views • 18 slides

375 views • 15 slides

Handling Post Approval Commitments & Follow Up Measures in the EU environment

281 views • 13 slides

235 views • 11 slides

After the inspection, a report of the findings is issued to the MAH

A preliminary notification to the Marketing Authorisation Holder (MAH) of statutory inspection is sent to the organisation, which includes a request for the Summary of Pharmacovigilance Systems (SPS). The inspection plan is developed with the MAH and finalised.

111 views • 1 slides