EAEU countries + UZ

Tuesday, 7 October 2025

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 - 9:30

INTRODUCTION /  Opening speecH

Dr. Aleš Rotar, Member of the Management Board

9:30 - 9:45

New members of Krka regulatory team – short presentation

9:45 - 11:15

Current situation of Krka’s registrations in EAEU

Melita Brajkovec (HQ RA) and local regulatory managers

11:15 - 11:45

Coffee break

11:45 - 13:15

Review of received Lod’s on New, Variation and MRP procedures

Sandra Hiti, Tadeja Bevec, Tina Skušek and Maruša Pompe

(HQ RA and RD)

13:15 - 14:15

Lunch break

14:15 - 15:15

Variations after MRP procedures

Gregor Hrovat (HQ RA)

15:15 - 16:15

Monitoring of EAEU legislation and changes

Melita Brajkovec (HQ RA)

16:30

Transport of Local regulatory colleagues to the hotel

EAEU countries + UZ

Wednesday, 8 October 2025

Krka, d. d., Novo mesto, Slovenia – Conference room 4/P / Online

08.30

Departure/Transport of Local regulatory colleagues from the hotel to Krka’s HQ

09:00 - 10:30

Pharmacovigilance

- Pharmacovigilance novelties EAEU and UZ


Irena Orel (HQ PV) and

Denis Makhnovskiy (local PV)

10:30 - 11:00

Coffee break

11:00 - 12:00

  • Pharmacovigilance - in conference room 4/P
  • Presentation of KPI - EAEU and UZ
  • PSUR deficiencies/LoDs



  • Parallel lecture: Reformulation (round table discussion) - in Krka hall


Živa Turšič (HQ PV)

Petra Tekavčič (HQ PV)

12:00 - 13:00

Lunch break

13:00 - 14:00

Harmonisation of SmPC/PIL of generics with

reference product – experiences within the markets

Bernarda Padovan and Jasna Grželj (HQ RA and MD)

Natalia Em (Local RA)

14:00 - 14:15

Pretex info 

Marija Krištof (HQ RA)

14:15 - 14:45

Conclusions 

HQ New products

14:45 - 15:45

Meetings between local representatives and HQ responsible person for country

15:45

Transport of Local regulatory colleagues to the hotel

EU, SEE and non-EAEU countries

Wednesday, 8 October 2025

Krka, d. d., Novo mesto, Slovenia – Krka Hall / Online

7:45

Departure/Transport of Local regulatory colleagues from the hotel to Krka’s HQ

8:00 - 8:30

Registration

8:30 - 9:15

INTRODUCTION /  Opening speecH

Dr. Aleš Rotar, Member of the Management Board

9:15 - 9:30

New members of Krka regulatory team – short presentation

9:30 - 10:30

New variation’s guidelines + new classification & Sharing experiences of WorkSharing

Klavdija Vertuš (HQ RA)

10:30 - 11:00

Coffee break

11:00 - 12:00

REFORMULATION – Exploring the case (roundtable discussion)

Marinka Fartelj, Tamara Trojko, Barbara Volarič, Janja Medved, Marta De Sepulveda, Lubica Galandova and Anja Birjukov

(HQ RA, RD, PMNP and local RA)

12:00 - 13:00

Lunch break

13:00 - 13:45

Sustainability (ESG) in the Krka Group

Uroš Ožbolt (HQ FS)

13:45 - 14:00

14:00 - 16:00

Pharmacovigilance

- novelties EU, SEE and non-EAEU

- VMD inspections

- Educational materials: DAM project


Irena Orel and Meta Krek (HQ PV)

Blanka Emeršič (HQ PV)

Petra Tekavčič, Alenka Šenk Erpič (HQ PV) and Jignasha Patel (local PV)

16:00

HQ New products

16:30

Transport of Local regulatory colleagues to the hotel

All participants

Thursday, 9 October 2025

Hotel Šport Otočec

9:30

Arrival to the Awards ceremony

10:00 - 11:00

REGULATORY AWARDS FOR BEST REGULATORY MANAGERS (at Hotel Šport Otočec)

11:30 - 12:30

Lunch

13:10

Departure to the team building location

13:30 - 19:00

Team building (wine tasting experience and entertaining quiz)

19:00

Closing & farewell

Transport of Local regulatory colleagues to the hotel

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

Registration Information

We kindly recommend that international participants arrive one day before the start of the conference:

  • Participants from EAEU countries + UZ: Monday, 6 October 2025
  • Participants from the EU, SEE, and non-EAEU countries: Tuesday, 7 October 2025


Conference Programme

The official programme of the Regulatory and Pharmacovigilance Conference begins as follows:


  • EAEU countries + UZ:
  • Tuesday, 7 October 2025
  • Registration: 08:15
  • Programme starts: 09:00


  • EU, SEE, and non-EAEU countries:
  • Wednesday, 8 October 2025
  • Registration: 08:00
  • Programme starts: 08:30


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 


Thursday, 9 October 2025, will start with the Regulatory Awards ceremony followed by a fun-filled afternoon of team building activities.


Useful Tips for Participants

We’re excited to welcome you to a special day filled with celebration, connection, and fun! To help you prepare, here are a few important tips and reminders:

🕘 Morning – Awards Ceremony at Hotel Šport Otočec

  • Dress Code: Please dress in business elegant attire – this is a formal event.


🍽️ Lunch

  • After the ceremony, we’ll enjoy lunch together before heading to the next part of the day.


🚌 Afternoon – Team Building Activity

The team building event will take place at Vinska klet Colnar, starting with an entertaining quiz followed by a wine tasting experience.

  • Departure Options from Hotel Otočec:
  • By bus at 13:30
  • On foot at 13:10 (approx. 30-minute walk)
  • Important:
  • Arrival at Klet Colnar is only possible by bus or on foot
  • Please note:
  • There is no parking available for personal vehicles.


🧳 What to Bring

  • Good mood and team spirit 😊


Team building groups

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.