HOW TO ACHIEVE KNOW-HOW

It is essential for regulators and company experts to keep up-to-date with science and technology by receiving first-hand information direct from a practitioner who offers solutions and support. 3R PHARMA CONSULTING provides basic introductory courses as well as specialised workshops and training courses tailored to the need of the customer. The courses can either be organised in-house or externally.

What we offer:

COURSES

  • Courses on chemistry, manufacturing and control (CMC) topics in pharmaceutical development for regulatory people at health authorities and pharmaceutical companies;
  • Courses on Stability Testing including design of cost-effective stability protocols and analysis of stability data, as well as generation of stability reports;
  • Courses on the Common Technical Document (CTD) Module 3 - Quality (ICH Guideline M4-Q).
  • Courses on Quality by Design (QbD), Real Time Release (RTR), Design Space, Fisher`s Design of Experiments (DoE)


CONFERENCES / WORKSHOPS

via not-for-profit organisations, e.g.

  • American Association of Pharmaceutical Scientists (AAPS)

via commercial conference companies, e.g.

  • informa Life Sciences
  • FORUM - Institut für Management
  • Pharma iQ
  • Arbeitsgemeinschaft für Pharmazeutische Verfahrenstechnik (APV)
  • Pharmaceutical Training International (PTI)

 

FORTHCOMING EVENTS


24-27 January 2012 | Langen [Germany]
EUCRAF Seminar Pharmaceutical development of biopharmaceuticals and particulars of the CMC dossier
25 January: "Stability of biopharmaceuticals"
 
21-22 March 2012 | Berlin [Germany]
21 March: "Managing Global Stability Requirements"
23 March: Post-conference Workshop
"Introduction to statistical evaluation of stability data"

RECENT EVENTS

2011

 
15-30 August 2011 | Online
Pharma iQ
 
30 May 2011 | Frankfurt am Main [Germany]
Hanson Wade "World Orphan Drug Summit"
Pre-Conference Workshop
“Orphan Medicinal Products in the EU”
 
20 April 2011 | Oegstgeest [The Netherlands]
SIR Institute for Pharmacy Practice and Policy
European Regulatory Affairs Course – Module II Quality
6-7 April 2011 | Berlin [Germany]
informa Stability Conference
 
21-23 February 2011 | Dubai [United Arab Emirates]
5th GMP Conference
 
7-9 February 2011 | Washington D.C. [USA]
DIA/AAPS joint CMC workshop "Translating Science into Successful Regulatory Submissions"
Session Chair "Stability by Design" and "Managing Stability Studies Globally"
 
12 January 2011 | Freiburg [Germany]
EUCRAF Seminar 4, Part I: CMC
“Stability of biopharmaceuticals”

 

2010

1 December 2010 | Bonn [Germany]
FORUM Conference "Global Quality"
"Global stability testing applying the Stability by Design concept"

22 November 2010 | Amsterdam [The Netherlands]
informa Conference on "Setting Specifications"
Pre-Conference Workshop "Setting shelf-life specifications based on global stability testing programmes"

14 November 2010 | New Orleans, Louisiana [USA]
AAPS Annual Meeting 2010 / FIP World Congress 2010
Pre-Conference Course "Stability Testing in Pharmaceutical Development"

19-20 October 2010 | Montreal [Canada]
IPA Stability Testing Conference

29 September 2010 | Cologne [Germany]
FORUM 7th Conference on Marketing Authorisation
"Global Quality for International Submissions - the Challenges in CMC"

16 September 2010 | London [UK]
Pharma iQ Conference "Stability Testing 2010"
"Update on the ICH and WHO Stability Guidelines"

14 September 2010 | London [UK]
informa Conference "QbD for Pharma"
Pre-Conference Workshop "Applying QbD Principles"

23-24 March 2010, London [UK]
informa Stability Conference

 

2009

16 November 2009 | London [UK]
informa Conference "Setting Specifications"
Pre-Conference Workshop
"Evaluation and Reporting of Analytical Data from Stability Studies"

13 November 2009 | Paris [France]
ProductLife Consulting
"Risk Management in CMC Variations Handling"

4 November 2009 | Oegstgeest [The Netherlands]
SIR Institute for Pharmacy Practice and Policy
European Regulatory Affairs Course
Regulatory aspects of pharmaceutical development

29-30 September 2009, Berlin [Germany]
informa "Temperature Controlled Pharmaceutical Distribution" Conference

24-25 September 2009, National Harbor, MD [USA]
aaps/PhRMA Workshop "Current Trends in Stability"

1-2 April 2009, Dublin [Ireland]
informa Stability Conference

29 January 2009, Brussels [Belgium]
The Honeywell Generics Forum 2009

2008

25-26 November 2008, Vienna [Austria]
informa 6th Annual Stability Testing

7-8 November 2008, Mumbai [India]
10-11 November 2008, Singapore
Stability Course

24-25 September 2008, Amsterdam [The Netherlands]
informa 3rd Annual Temperature Controlled Pharmaceutical Distribution

28 August 2008, Frankfurt am Main [Germany]
Colloquium Pharmaceuticum
Implementierung von ICH Q8, Q9, 10

28-29 April 2008 | Mumbai [India]
DIA 1st Indian Annual Regulatory Conference
GMP Requirements for Active Pharmaceutical Ingredients (API)

16-18 April 2008 | Oegstgeest [The Netherlands]
SIR Institute for Pharmacy Practice and Policy
European Regulatory Affairs Course
Regulatory aspects of pharmaceutical development

1-2 April 2008 | Dublin [Ireland]
informa Conference Stability Testing 2008
The new WHO stability guideline - understanding the impact

11-12 February 2008 | Toronto [Canada]
IPA Conference Stability Program Design and Development
Update on Stability Requirements around the Globe
Interpretation of temperature monitoring data

28-30 January 2008 | Brussels [Belgium]
IQPC Conference Cool Chain Europe 2008
Calculating the Impact of Temperature Excursions on the Shelf-Life of a Product