Cycles of regular pharmaceutical regulatory seminars AUTUMN 2016 and SPRING 2017
Radisson Blu Plaza Hotel Ljubljana (Slovenian language)
In the cycles of regular pharmaceutical regulatory seminars Autumn 2016 and Spring 2017 we have prepared a comprehensive education in the field of pharmaceutical regulatory affairs. The education offers understanding and managing of the regulatory affairs of medicinal products as a whole and as well a deepening into specific areas. This time, Cycles will be organised as ten individual seminar, five in the autumn and five in the spring series.
Education is intended for assosiates in the pharmaceutical industry working in different areas, from medicinal products developement to regulatory departments and marketing, for assosiates in competent authorities and others who need the aforementioned skills. Specialised skills do not suffice to make suitable decisions in practice, one needs to understand the whole and as well the consequences of decisions. As this is one of the most regulatad areas in the EU legislation, it is in order to occasionally refresh the existing knowledge, as a precondition for highly professional task performance in this field.
Seminars are run by Vesna Koblar, MD. PhD. with guests, experts in certain areas.
AUTUMN 2016
Seminar 1
INTRODUCTION TO EU PHARMACEUTICAL REGULATORY ACQUIS AND HOW TO ACHIEVE ITS GOALS: HIGH LEVEL OF PUBLIC PROTECTION AND COMPETITIVENESS OF PHARMACEUTICAL INDUSTRY
5th December 2016, 14 h – 17 h
Seminar 2
MARKETING AUTHORISATION PROCEDURES AND DOCUMENTATION, SPECIFIC REQUIREMENTS
6th December 2016, 14 h – 17 h
Seminar 3
VARIATIONS TO MARKETING AUTHORISATION AND EXTENSION LINES
7th December 2016, 14 h – 17 h
Seminar 4
TYPES OF APPLICATION FOR MARKETING AUTHORISATION; CHOICES, REQUIREMENTS, STRATEGIC USE IN PRACTICE, THE MOST COMMON ERRORS
8th December 2016, 14 h – 17 h
Seminar 5
REGULATORY SPECIFICS OF BIOLOGICAL MEDICINAL PRODUCTS AND ADVANCED THERAPY MEDICINAL PRODUCTS
9th December 2016, 14 h – 17 h
SPRING 2017
Seminar 6
PHARMACOVIGILANCE
3rd April 2017, 14 h – 17 h
Seminar 7
CLINICAL INVESTIGATION OF MEDICINAL PRODUCTS
4th April 2017, 14 h – 17 h
Seminar 8
ADVERTISING AND INFORMING ON MEDICINAL PRODUCTS
5th April 2017, 14 h – 17 h
Seminar 9
BORDERLINE PRODUCTS IN THE PHARMACEUTICAL INDUSTRY
6th April 2017, 14 h – 17 h
Seminar 10
COMBINATION PRODUCTS: MEDICINAL PRODUCT – MEDICAL DEVICE AND NEW REGULATIONS
7th April 2017, 14 h – 17 h
Click HERE for more information.
Click HERE to apply for seminars.