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Variation Workshop in Zagreb, Croatia - in Collaboration with HALMED and the Croatian Pharmaceutical Industry
- Dialogue, explanations, clarification
Registration deadline:
30 April 2017
Exam:
There is no exam in connection with the workshop  

Price:
Authority/Agency employee:  EUR 160 ex VAT
Industry employee:                 EUR 300 ex VAT
 
Startdate:
4 May 2017 - 5 May 2017
Purpose:
In a collaboration between The Croatian Pharmaceutical Industry and HALMED a 2-days workshop on variations is being offered in Zagreb, Croatia on May 4 - 5, 2017!
The workshop will take place at Hotel Westin Zagreb, Croatia. We have been offered a special price of EUR 133 for the participants of the conference. Contact person:
 
Ms. KATARINA
ŠIMATOVIĆ
 
THE WESTIN ZAGREB
Kršnjavoga 1, 10 000, Zagreb, Croatia
T  385 1 4892 025   F  385 1 48 92  091
E katarina.simatovic@westinzagreb.com
www.westin.com/zagreb
 
Dialogue, explanations, clarification
The EU variation regulation went through a major revision in 2008 and was further amended in 2012. Now, almost 10 years later it can still be difficult for authorities and industry to have a common interpretation of the regulation. Therefore continuous dialogue and education is needed.

This workshop will address a number of the questions that marketing authorization holders (MAHs) may have on variation procedures and provide an overview of the EU legislation concerning the different types of variations. The main focus will be on the variation guideline, how to classify a variation according to the guideline, how and when to submit a variation and finally how to implement changes. Moreover, we will have a session on work-sharing and grouping as well as on when to use these submission pathways.
 
Meet Croatian and other National European Authorities and Industry Leaders
The workshop will have lecturers from different European authorities such as HALMED/Croatia and BfArM/Germany as well as the industry, and we will discuss challenges seen both from the perspectives of authorities and industry. We will mainly cover submissions via the MRP/DCP and national procedure. Panel sessions and group work will highlight different challenges and ensure that the audience can take an active part in the debate.  
 
What Regulation and Guidelines will be covered?
The workshop will take its off-spring in Regulation 1234/2008, amended with Regulation 712/2012 as the legal basis and also the guidelines on the Details of the Various Categories of Variations, on the Operation of the Procedures Laid Down in Chapters II, IIa, III and IV of Commission Regulation (EC) No 1234/2008 of 24 November 2008 Concerning the Examination of Variations to the Terms of Marketing Authorisations for Medicinal Products for Human Use and Veterinary Medicinal Products and on the Documentation to be Submitted Pursuant to Those Procedures.
 
Content:
Links to Regulation and Guideline
Integrated version of Regulation 1234/2008 with Regulation 712/2012
Click here to download

Guidelines on the Details of the Various Categories of Variations, on the Operation of the Procedures Laid Down in Chapters II, IIa, III and IV of Commission Regulation (EC) No 1234/2008 of 24 November 2008 Concerning the Examination of Variations to the Terms of Marketing Authorisations for Medicinal Products for Human Use and Veterinary Medicinal Products and on the Documentation to be Submit-ted Pursuant to Those Procedures, 02-Aug-2013 (OJEU no. C 223, 02-Aug-2013, page 1.)
Click here to download

Learning Aims/Outcome
At the end of the seminar you will have an overview and practical understanding of the variation egulation and the classification guideline. You will be familiar with the different types of variations and know how to use grouping and worksharing. Moreover, you will have an understanding regarding what is important for a submission to get it right the first time. 
Workshop Facilitators
• Velimir Šimičevič, Regulatory Affairs Manager, Servier Pharma d.o.o., Croatia
• Inge Abildgaard, Regulatory Affairs Manager, Shire, Denmark
• Mette Schou-Hanssen, Project Leader, ALK Abelló A/S, Denmark
 
Programme

Thursday May 4, 2017
The EU Variation System
09.00 – 09.30 Welcome and Introduction to the Workshop  
Medicademy/Facilitators/Participants
 
09.30 – 11.30 The Variation Regulation – Setting the Scene for EU Regulators
• Background for the Variation System
• Use of Best Practice Guideline
• Classification depending on Risk
• Impact on Quality, Safety and Efficacy
Jasna Ikić Komesar, Principal Advisor for Regulatory Affairs, HALMED – Agency for Medicinal Products and Medical Devices of Croatia
Peter Bachmann, Senior Expert, European Drug and Regulatory and International Affairs, German Federal Institute for Drugs and Medical Devices (BfArM), Germany
 
11.30 – 11.45 Break
 
11.45 – 13.15 Classification in Practice
• Administrative
• Quality
• Safety, Efficacy, Pharmacovigilance
• PMF/VAMF
• Unforseen Variations
• Other
Hanne Brokopp, Director, Regulatory Affairs Europe, Merck, Sharp & Dohme (Europe), Belgium
Speakers from Belupo, Croatia - Confirmed but not named
 
13.15 – 14.15 Lunch
 
14.15 – 15.45  Grouping and Work-sharing
• Wrap-up on the Procedures
• Examples from Real-life
Representative from Other National Agency
Hanne Brokopp, Director, Regulatory Affairs Europe, Merck, Sharp & Dohme (Europe), Belgium 
 
15.45 – 16.00 Break 
 
16.00 – 16.45 Panel Session
• How does this work for us?
• Which challenges do we have?
• Solutions?
Representatives from HALMED, Other National Agency, Innovator Company, Generic Company 
 
16.45 – 17.45 Brain-storm Session and Closing Remarks
Participants, Facilitators, Speakers
 
 
Friday May 5, 2017 
08.45 - 09.00 Wrap-up from Day 1
Facilitators
 
09.00 – 11.00 Preparation and Submission
 - Focus on Examples from Real-life and with and without Labelling Impact

• Filling in the eAF: Practical Examples from different Classifications
• Prepare the Documentation Package
• Product Information Changes
• Variations with Labelling Impact
• Translations, Submissions and Timelines
• When do CTs occur?
Zrinka Srkoč, MPharm, Regulatory Affairs Manager, Roche d.o.o., Croatia
Representatives from HALMED
 
11.00 – 11.15 Break

11.15 – 12.45 Group Work
Participants, Facilitators, Speakers

12.45 – 13.45 Lunch

13.45 – 14.45 Procedures, Approvals and Implementation
• Timelines
• Clock Stop
• Responsibilities
• End of Procedures Messages
• Follow-up Measures
Velimir Šimičevič, Regulatory Affairs Manager, Servier Pharma d.o.o., Croatia
Representative from HALMED

14.45 – 15.30 Panel Discussion on Submissions
• How does this work for us?
• Which challenges do we have?
• Solutions?
Representatives from HALMED, Other National Agency, Innovator Company, Generic Company

15.30 – 15.45 Break

15.45 – 16.45 Brain-storm Session and Closing Remarks
Participants, Facilitators, Speakers
 
16.45 – 17.15 End of Workshop
Participants, Facilitators, Speakers
 
Target:
The seminar is open to all with an interest in the variation regulation, but the target audience is profes-sionals within:
• Competent Authorities
• Companies, HQ and Affiliate involved in Regulatory Affairs
 
 
 
 
Plads til diskussion – rigtig godt​
Ann-Lisbeth Aarup Nielsen - ALK-Albelló - Regulatory Affairs Officer

 

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