PROGRAMME
All participants
Monday, 14 September 2026
Krka, d. d., Novo mesto, Slovenia – Krka Hall / Online
8:00
Departure/Transport of Local regulatory colleagues from the hotel to Krka’s HQ
8:15 - 9:00
Registration
9:00 - 9:45
INTRODUCTION /
Opening speecH
Suzana Kolenc, Director of New products
9:45 - 10:00
New members of Krka regulatory team – short presentation
10:00 - 10:45
Strategy, Corporate Finance and Investing: The Krka Perspective
Uroš Ožbolt, HQ Finance director
10:45 - 11:15
Coffee break
11:15 - 12:00
Text management and implementation
Špela Čerpič Varlec, HQ Technology elements for production
Blaž Krivec, HQ Supply chain management
Klavdija Vertuš, HQ Regulatory Affairs
12:00 - 13:30
Lunch break
13:30 - 15:00
Smart Use of AI / Artificial Intelligence in Regulatory Affairs - presentation and roundtable discussion
Matej Golob Managing Partner, CorpoHub; AI Expert
Round table participants: Kim Zelič, Bojana Ločičnik, Carsten Oelkers, Ilina Katsarova, Jelena Simić, Evgeniya Samlyukova.
15:00
Transport of Local regulatory colleagues to the hotel
All participants
Tuesday, 15 September 2026
Krka, d. d., Novo mesto, Slovenia – Krka Hall / Conference room 4/P / Online
08.00
Departure/Transport of Local regulatory colleagues from the hotel to Krka’s HQ
08:30 - 09:15
- New EU General Pharmaceutical Legislation
- Paralell lecture: Overview of current situation per country + plan EAEU variations and renewals - in Conference Room 4P
Špelca Jenko, HQ Regulatory Affairs
HQ RA, local regulatory managers EAEU - RU, KG, KZ, BY, AM Presentations/discussion will be partly held in RU language
09:15 - 10:00
- One Data Source, Many Business Processes
- Paralell lecture: Overview of current situation per country + plan EAEU variations and renewals - in Conference Room 4P
Kim Zelič/Jaka Petrič, Informatics in Projects and Regulatory Affairs
HQ RA, local regulatory managers EAEU - RU, KG, KZ, BY, AM
Presentations/discussion will be partly held in RU language
10:00 - 10:30
Break
10:30 - 11:00
- The Patent Perspective: Key Patent Milestones on the Registration Path
- Paralell lecture: EAEU Text and Mock-up preparation - in Conference Room 4P
Barbara Kunič, HQ Head of Industrial Property
Bernarda Padovan, HQ Regulatory Affairs, Iza Pekle Simonič, HQ Medical development
11:00 - 11:30
- Regulatory Management of Indication Patents: Key Challenges and Insights
- Paralell lecture: EAEU Veterinary procedures - in Conference Room 4P
Bernarda Bevc, HQ Regulatory Affairs
Matija Krajnik, HQ Regulatory Affairs
Presentations discussion will be partly held in RU language
11:30 - 12:00
Individual meetings for local regulatory managers and HQ RP per country
12:00 - 13:00
Lunch
13:15
Departure to social event - location Bled, Slovenia
21:00
Departure to Novo mesto from Bled
All participants
Wednesday, 16 September 2026
Krka, d. d., Novo mesto, Slovenia – Krka Hall / Online
8:00
Departure/Transport of Local regulatory colleagues from the hotel to Krka’s HQ
Participants: All participants (HQ New Products, local regulatory managers) + MRF
8:15 - 9:00
Opening speecH
Aleš Rotar, Member of the Management Board and Director of Pharmaceutical Research & Development and Production)
9:15 - 9:30
Pharmacovigilance – novelties in human and veterinary pharmacovigilance
HQ Pharmacovigilance, Irena Orel, Rok Pejović
Participants: LRP (local responsible persons for pharmacovigilance) + MRF
10:00 - 11:00
- Inside Pharmacovigilance department
- Medical Assessment
- Personal data protection and use of AI
- PSMF
Teja Barle, HQ Pharmacovigilance
Manca Urh, HQ Pharmacovigilance
Meta Krek, HQ Pharmacovigilance
Ajda Kokalj, HQ Pharmacovigilance
11:00 - 11:30
Break
12:00 - 13:00
Participants: EU, SEE and non-EAEU (Krka Hall)
- Educational materials management - DAM project
- MedDRA presentation
Participants: EAEU (4/P Conference Room
EAEU Pharmacovigilance
- EAEU novelties
- Kazakhstan inspection preparation
Petra Tekavčič, HQ Pharmacovigilance/ Joao Silva, Krka Portugal
Nataša Nagelj Kovačič, Patricia Luštek, HQ Pharmacovigilance
Denis Makhnovskiy
Denis Makhnovskiy, Anastassiya Yakhyayeva, Živa Turšič
12:30 - 13:30
Lunch break
13:30 - 14:15
Conclusions
14:00 - 16:00
Individual meetings for local regulatory managers and HQ RP per country
HQ Regulatory Affairs, local regulatory managers
LOCATION
The conference will take place at Krka, d.d., Novo mesto, Slovenia and online.
ACCOMODATION
The participants will be accommodated in Krka’s capacities at Hotel Šport Otočec.
Full-board service (with breakfast, lunch and dinner) will be organised for all the participants at hotel and in KRKA, d. d., Novo mesto.
ARRIVAL AND DEPARTURE
Programme:
The official programme of Regulatory and pharmacovigilance conference begins on Monday, 14 September 2026 at 09.00, following the registration at 08.00.
The pharmacovigilance part of the conference will be held on Wednesday, 16 September 2026.
Departure is possible after 15.00 – after the last session on 16 September 2026.
Transportation:
All transfers (to/from the airport, hotel, etc.) will be arranged.
When booking your flights, please consider the travel time from Krka Headquarters in Novo mesto to the airports:
- Jože Pučnik Airport, Ljubljana: approximately 3 hours
- Franjo Tuđman Airport, Zagreb: approximately 3 hours
Travel Documents:
Please ensure you have all the necessary documents for your stay in Slovenia (e.g., passport, visa, Letter of Guarantee, etc.), if applicable.
For any questions regarding accommodation or transport, feel free to contact us at: Regulatory.Affairs@krka.biz
REGULATORY AWARDS & SOCIAL EVENT
Monday, 14 September 2025, the Regulatory Awards ceremony
Join us for an evening dedicated to recognizing excellence in regulatory affairs at the Regulatory Awards for Best Regulatory Managers ceremony. The awards ceremony will be followed by a dinner and networking reception in front of Krka Hall.
Location: Krka Hall
Time: 19:00
Dress Code: Elegant attire is recommended.
Tuesday, 15 September, Social event
On Tuesday, participants are invited to join us for a social event in Bled, one of Slovenia's most beautiful and iconic destinations.
Further details regarding the programme and schedule will be provided during the conference. We recommend wearing comfortable clothing and footwear.
More information about the destination is available through Bled Tourism.
We look forward to welcoming you to an enjoyable and memorable experience.
COSTS
KRKA, d. d., Novo mesto will settle all the expenses for the accommodation and meeting facilities, meals, coffee and refreshments that will be served during the morning and afternoon breaks and social events during this conference.
Colleagues from Krka companies will receive Invoices to their headquarters.
The accommodation per person per day is:
Tourist tax per day is 2.50 €.
Other expenses, such as mini-bar, room service, laundry, telephone calls are not covered by Krka. You should pay for these either by cash or card when you check out of the hotel.
