APV/IPEC Europe Excipient Conference 2018  | KN 3190

An update on regulatory developments and their application 18.09. - 19.09.2018 | Köln, Germany

Veranstaltungsort

Lindner Hotel City Plaza
Magnusstraße 20
50672 Köln
Tel.:+ 49 221 2034 700
E-Mail:info.cityplaza@lindner.de

Dear Colleagues,
IPEC Europe and APV are delighted to invite you to our 7th annual conference on pharmaceutical excipients.
The conference will focus on “hot topics” in the area of excipient regulation and technology.
As part of the programme we will offer three parallel workshops to provide practical, hands-on insight and discussion on regulatory topics, with a view to IPEC Guidelines providing tools to achieve compliance. These workshops will focus on implementation of GMP in an excipient manufacturing site, supplier qualification and auditing, as well as analytical data and certificates of analysis provided by suppliers of excipients.
Beyond that the regulatory session will highlight compendial topics of EDQM and USP. Challenges relating to the control of particulate contamination in excipients and requirements for excipients in parenteral applications will be presented and discussed by industry experts from pharma industry.
The technical and scientific part of the conference will deal with the importance of excipient on drug bioavailability.
Low bioavailability is most common with oral dosage forms of poorly water-soluble, slowly absorbed drugs. Lipid based drug delivery system will be presented and can be an approach to overcome low bioavailability.
The way of drug release from modified-release (MR) dosage forms is intentionally different from that of a immediaterelease drug formulation to produce a desired therapeutic purpose or improved patient compliance. Here we will discuss a method to predict the modified release performance of drugs.
Molecules used as active drug substances can be categorised into two classes – small and large molecules. Small, chemically synthesised molecules are the conventional active substances and still constitute over 90 percent of the drugs available on the market today. Contrary to small molecules, large molecules are complex and often consist of heterogeneous mixtures; they are becoming increasingly important. We will highlight the role of excipients in small/large molecule drug formulation.
New scientific findings in the molecular processes of life are advancing our knowledge of health and disease. The objective of individualized medicine is to make such knowledge useful for individually tailored prevention, diagnosis and treatment. As new drugs are elaborated that have differential effects within populations, there is also a need to consider new manufacturing methods. The requirements of excipients for individualised medicines and continuous manufacturing processes will be pointed out.
Last but not least networking and exchange of information is a key feature of the event and table-top exhibitions aligned to the conference will encourage communication between suppliers and users.
We are looking forward to welcoming you in Cologne.

Dr. Frank Milek, Vice-Chair IPEC Europe
Dr. Mahmud Yunis, IPEC Europe Board Member

Table Top Presentation

Sponsoring opportunities can be download here

Kursprogramm zum Download

Zielsetzung

This event is designed to highlight current hot topics in the field of pharmaceutical excipients:

  • Implementation of GMP in an excipient manufacturing site
  • Qualification and auditing of suppliers
  • Analytical data and certificates of analysis for excipients
  • The European Pharmacopoeia’s General Methods Modernisation Programme
  • USP – Strategies and Opportunities for Excipient Standard Setting
  • Particulate matter in pharmaceutical starting materials and drug products
  • Regulatory and technical challenges for excipients in parenteral formulations
  • Formulation topics

    • Impact of excipients on oral drug bioavailability
    • Lipid-based drug delivery systems (to overcome poor API solubility/bioavailability)
    • Analysing Thermo-Sensitive Properties of HPMC to predict Modified-Release Performance
    • Small molecules: The Effect of excipients on small molecules
    • Large molecules: Thermodynamic approach to explore excipient-mixture and novel excipients in high concentration protein formulations
    • Individualised medicines - the role of excipients
    • Continuous Manufacturing: A systematic Approach for defining Key Excipient Attributes for Continuous Feeding

Kooperationspartner

ipec EUROPE

Preise

  Bis 30.06.2018 Vom 01.07.2018
Industry 1.490,00 € 1.590,00 €
Authorities 745,00 € 795,00 €
Alle Preise zzgl. VAT(19.00% MwSt.)

Veranstalter

APV GmbH

Tel.: +49 6131 97690
Fax: +49 6131 976969
E-Mail: apv@apv-mainz.de
www: https://www.apv-mainz.de/apv/