We think you have liked this presentation. If you wish to download it, please recommend it to your friends in any social system. Share buttons are a little bit lower. Thank you!
Presentation is loading. Please wait.
Published byRobyn Liggett
Modified over 2 years ago
© Safeguarding public health BROMI Variations ·Launch Meeting The Cumberland Hotel, London Anne Ambrose 8 th May 2008
Slide 2 May 2008 © BROMI - Variations Variations – High Volume work stream Approx 22,000 variation applications received annually in UK. 50% Type IA 80% National Risk based approach to assessment. Reduction in administrative burden. Predictable approval times Delivery of new ways of working.
Slide 3 May 2008 © Current Regulatory Framework Regulation EC 1084/2003 – Mutual Recognition Regulation EC 1085/2003 – Centralised Procedure UK – Follows principles of Regulations EC1084/2003 and EU Best Practice Guidance
Slide 4 May 2008 © BROMI Concepts
Slide 5 May 2008 © Variations – Proposal for 3-tier model for certain categories of change – Based on MR procedures Self Certification Scientific Validation (IA) 30 Day Assessment (IB) Type IA Type IB Type II
Slide 6 May 2008 © BROMI - Variations Choice of Categories for Self Certification or Expedited Processing: Review of National applications determined by MHRA. Categories with low number of invalidation/refusals. Changes that had become Type II with introduction of 1084/2003EC.
Slide 7 May 2008 © Variations – 3 tier model Self Certification BROMI – ‘Tell and do’ -Approx 80% of current Type IA; -Approx 7000 per annum in UK Type IA BROMI – 14 day scientific validation Type IB BROMI – 30 day assessment procedure
Slide 8 May 2008 © BROMI -Variations How would the 3-tier model help my company? Change in name and address of MA Holder (same legal entity) Current – Type IA with 14 Day validation procedure BROMI – Self Certified change that can be implemented immediately
Slide 9 May 2008 © Minor Change in the Manufacture of the Active Ingredient Current – Type IB 30-Day assessment procedure BROMI – Under certain conditions Type IA 14-Day validation Replacement or addition of a manufacturer for a sterile product Current – Type II 90-Day assessment procedure BROMI – Type IB 30-Day assessment procedure
Slide 10 May 2008 © BROMI Variations Pilot Initial Phase 1 st February – 31 st July 2007 Limited Number of Companies (11 company groups) Use of Sentinel Portal Audit Evaluation Pilot extended to 31 st January 2008
Slide 11 May 2008 © BROMI Variations Pilot – Participating Companies Galpharm GSK Lundbeck Organon Pliva Pfizer Reckitt Benckiser Rosemont Sanofi- Aventis Teva Wockhardt
Slide 12 May 2008 © Procedures for Submitting BROMI Notifications Self Certification: Acknowledgment issued as MAH submits application through Sentinel Portal Sentinel/Rama records updated in 14-Days and formal acknowledgment letter issued
Slide 13 May 2008 © BROMI Variations Applications Submitted In total 609 BROMI Variations received during the 6 month pilot BROMI Self Certification = 518 BROMI Type IA= 74 BROMI Type IB= 17
Slide 14 May 2008 © Applications Submitted
Slide 15 May 2008 © BROMI Self Certification
Slide 16 May 2008 © Audit Outcome Common Mistakes on applications - Omission of Declaration Form - - Omission of updated PL and/or label - Inadequate QP Declarations - Multiple Ph Eur CEPs in a single notification Most common categories for error - Changes to Tablet or Capsule Markings -Change to Batch Release and QC Arrangements – QP Declarations -Manufacturer of active, – documentation -Change in company name/address
Slide 17 May 2008 © BROMI Variations Pilot Company Questionnaire Approval time – great advantage. Admin burden – further reduction required. Guidance and Procedure – further simplification required. Pilot extended to 31 st January 2008
Slide 18 May 2008 © Extension of Pilot Categories reviewed – Change #8. Batch release removed. Simplify guidance. Reduce Documentation Requirements. Improved audit
Slide 19 May 2008 © Applications Received Feb 07 – Jan 08 Approx 1,500 applications received in total 900 Self-Certified
Slide 20 May 2008 © BROMI – Variations Final evaluation of pilot Full Roll-out to MAHs. National Applications Portal Applications Next Steps Further amendments to Sentinel process and letters issued
Slide 21 May 2008 © Next Steps Revision of EU Variation Regulations Two categories of Type IA notification -Those requiring immediate notification -Those that can be included in an annual update Downgrading of variations that have received a scientific opinion
Slide 22 May 2008 © Do you have any further suggestions?
BROMI Variations Training Meeting 8th May 2008 BROMI Variations – An Industry Perspective Helen Darracott Director of Legal & Regulatory Affairs, PAGB.
BROMI Variations Training Meeting 8 May 2008 BROMI Variations – Training Presentation BROMI Variations Training Meeting, 8 th May 2008, The Cumberland.
WEEK 1 You have 10 seconds to name…
Addition 1’s to
Safeguarding public health © Crown copyright 2008 BROMI eSubmissions Case study using the MHRA Portal : Tesfa Rodway – Information Systems Training Officer.
Addition Facts = = =
Jeopardy Topic 1Topic Q 1Q 6Q 11Q 16Q 21 Q 2Q 7Q 12Q 17Q 22 Q 3Q 8Q 13Q 18Q 23 Q 4Q 9Q 14Q 19Q 24 Q 5Q 10Q 15Q 20Q 25 Final Jeopardy.
25 seconds left….. 24 seconds left….. 23 seconds left…..
BROMI Variations Training Meeting 8th May 2008 Case Study Session BROMI VARIATIONS.
DIVIDING INTEGERS 1. IF THE SIGNS ARE THE SAME THE ANSWER IS POSITIVE 2. IF THE SIGNS ARE DIFFERENT THE ANSWER IS NEGATIVE.
McDonald’s calendar 2009 January
Chapter 5 Test Review Sections 5-1 through 5-4. Simplify each expression. 1)2) 3)4) 5) 6)
Health and Consumers Health and Consumers Regulation of Food Additives in the EU MeatCoat research programme 27 May 2014 Wim Debeuckelaere European Commission,
SARQA/DKG Conference 3-4 October SARQA/DKG Conference 3-4 OCTOBER 2002 Annex 13 Update An Industry Perspective Michael J Cooke Director, Global.
We will resume in: 25 Minutes We will resume in: 24 Minutes.
By D. Fisher Geometric Transformations. Reflection, Rotation, or Translation 1.
January 10, 2008www.infosecurity.ca.gov/1 Role, Responsibility and Authority of New Office Presented by Colleen Pedroza, State Chief Information Security.
TWO STEP EQUATIONS 1. SOLVE FOR X 3. DIVIDE BY THE NUMBER IN FRONT OF THE VARIABLE 2. DO THE ADDITION STEP FIRST.
Effects on UK of Eustatic sea Level rise GIS is used to evaluate flood risk. Insurance companies use GIS models to assess likely impact and consequently.
Year 6 mental test 10 second questions Addition and Subtraction Addition.
1 THE CERTIFYING AUTHORITY How the Certifying Authority can deliver assurance? How the Certifying Authority can deliver assurance? Adérito Pinto European.
Slide 1 Advanced Piloting Cruise Plot. Advanced Piloting Cruise United States Power Squadrons ® Part I Question 1 Question 2 Question 3 Question 4 Question.
The European Agency for the Evaluation of Medicinal Products 1 FFUL LisbonHilde Boone - EMEA 29 May 2003 EU Variation Regulations (541/95 and 542/95) Final.
Module N° 1ICAO Safety Management Systems (SMS) Course 1 Revision N° 13ICAO Safety Management Systems (SMS) Course06/05/09.
1 The assurance model for the programming period – How is the Commission building up its assurance ? Caroline Callens Deputy Head of Unit J.1:
1 European Commission Taxation and Customs Union European Commission Taxation and Customs Union.
PLAYBOY Kalender 2007 Dit is wat mannen boeit! Januari
© Charles van Marrewijk, An Introduction to Geographical Economics Brakman, Garretsen, and Van Marrewijk.
1 Management verifications Michael Ryan Axel Badrichani
1 Unit 1 Kinematics Chapter 1 Day
For a CLEAN GREEN Dallas New Once-Weekly Service for Recycling and Garbage Town Hall Meeting February 7, 2008.
1 Copyright © 2010, Elsevier Inc. All rights Reserved Fig 2.1 Chapter 2.
© 2012 National Heart Foundation of Australia. Slide 2.
MULT. INTEGERS 1. IF THE SIGNS ARE THE SAME THE ANSWER IS POSITIVE 2. IF THE SIGNS ARE DIFFERENT THE ANSWER IS NEGATIVE.
1 Chapter 1 The Study of Body Function Image PowerPoint Copyright © The McGraw-Hill Companies, Inc. Permission required for reproduction or display.
Copyright © 2008 Cengage Learning Understanding Generalist Practice, 5e, Kirst-Ashman/Hull 1.
Business Transaction Management Software for Application Coordination 1 Business Processes and Coordination.
Petr Cerveny Unit Administration and Finance 31/5/2010 Major FP7 Negotiation Issues.
Document #07-2I RXQ Customer Enrollment Using a Registration Agent (RA) Process Flow Diagram (Move-In) (mod 7/25 & clean-up 8/20) Customer Supplier.
Here it is ladies and gentlemen !!!!! The Pirelli calendar for 2009 You are the first person to receive this new Pirelli- calendar for 2009 This is the.
Januar 2005 S M T O T F L
SUBTRACTING INTEGERS 1. CHANGE THE SUBTRACTION SIGN TO ADDITION 2. TAKE THE INVERSE OF THE SECOND NUMBER 3. FOLLOW THE RULES FOR ADDITION 4. ADD THE OPPOSITE.
1 Workshop on inventories of greenhouse gas emissions from aviation and navigation May 2004, Copenhagen EU greenhouse gas emission trends and projections.
© 2017 SlidePlayer.com Inc. All rights reserved.