Susanne Ding, Boehringer Ingelheim, Germany
Dr Ulrich Kissel, European QP Association
Savvas Koulouridas, Fagron BV, The Netherlands
Aidan Madden, FivePharma, Ireland
Sue Mann, Sue Mann Consultancy, U.K.
Rico Schulze, State Ministry of Social Affairs and Consumer Protection, Saxony, Germany
Lance Smallshaw, UCB, Belgium
Brenda Van Assche, Janssen, Belgium
Pre-course IMP Session:
This pre-course session provides a detailed overview of the specific characteristics in IMP manufacturing a QP must know to certify IMP batches for the release for clinical Trials.
QP Education Course:
Broaden and intensify your knowledge of the Qualified Person’s duties and responsibilities. Experts from the EQPA Board of Directors, pharmaceutical industry and regulatory authority will share their experience on important issues of the QP’s daily business and will give first-hand information on current and future expectations.
Pre-course IMP Session:
The manufacture of investigational medicinal products (IMPs), including labelling, packaging, testing and certification, is carried out in accordance with the applicable GMP regulations. However, this is not a routine process, since, among other things, manufacturing and packaging procedures might be different for each and every clinical trial. The Qualified Person (QP) must therefore take into account these particularities and the GMP/GCP interface.
QP Education Course:
Over the last years the role and responsibilities of the Qualified Persons have been increasing considerably. As a key person in the company, the QP has to consider many issues and has to take up the challenges within its areas of responsibilities. Additionally, as laid out in Article 49 of the European Directive 2001/83/EC, the QP needs to be highly qualified and experienced. This education course is one important part to help the QP be on top of current developments in GMP and regulatory requirements.
Pre-course IMP Session:
New colleagues becoming IMP QPs, QPs looking for continuous training and personnel of CROs and “non-commercial” IMP organisations.
QP Education Course:
New and future Qualified Persons, QPs who are looking for ongoing training and personnel who want to get a detailed overview of the role and responsibilities of a QP.