Annual Meeting Icon

Annual Meetings » Annual Meeting 2015 » Programme
20141 20142 20143 20144 20145 20146

Programme

5th ANNUAL BIOPHARMACEUTICALS MEETING

What currently matters for Biopharmaceuticals

5 - 6 February 2015

Munich, Germany
Holiday Inn Munich - City Centre
Chairs: Johannes Löwer - Gabriele Dallmann

 Flyer

DAY 1, THURSDAY, 5 FEBRUARY 2015

09.00 - 09.45 Registration and welcome coffee
09.45 - 10.00

Welcome to the annual meeting
To kick-off the meeting we welcome our speakers and participants with breakfast snacks. Start the day by meeting your colleagues, think of topics or questions which could be raised during the days. We have cards ready to write them down and hand over to the Chairs of the annual meeting.

10.00 - 10.30
Regulation and other factors influencing the development of biopharmaceuticals
The innovator´s perspective
Joyce Tait, Innogen Institute, UK
10.30 - 10.45
Discussion

SESSION: 1   ROUNDUP OF THE LAST YEAR ON REGULATORY ACTIVITIES IN EUROPE AND THE US

10.45 - 11.15

News and trends in Europe: Update on the last year. Marketing Authorisation and guideline activities
Christian Schneider, Danish Health and Medicines Authority, CHMP Member

11.15 - 11.45

An update on the activities of the CAT
Sol Ruiz, Spanish Medicines Agency, CAT Member

11.45 - 12.00

Session 1 panel discussion
Featuring: Christian Schneider (Danish Health and Medicines Authority, CHMP Member), Sol Ruiz (Spanish Medicines Agency, CAT Member) and Jian Wang (Health Canada)

SESSION 2:   AN UPDATE ON THE PDCO ACTIVITIES

12.00 - 12.30

Where to go in the EU with the Paediatric Investigational Plan (PIP)? An update on the most recent PDCO work
Dirk Mentzer, Paul-Ehrlich-Institut, PDCO Chairman

12.30 - 12.45
Discussion
12.45 - 13.45
Lunch break

SESSION 3:   BIOSIMILARS

13.45 - 14.15

News and trends in Europe: An update on the EMA Biosimilar Medicinal Products Working Party (BMWP)
Martina Weise, BfArM, Vice-Chair BMWP

14.15 - 15.00

News and trends in the US: Update on biosimilars in the US
Steven Kozlowski, FDA

15.00 - 15.30

Case study: Approval of biosimilar infliximab in Canada
Jian Wang, Health Canada

15.30 - 16.00
Session 3 panel discussion
Featuring: Martina Weise (BfArM), Christian Schneider (Danish Health and Medicines Authority), Steven Kozlowski (FDA), Jian Wang (Health Canada)
16.00 - 16.20
Coffee break

SESSION 4:   HTA

16.20 - 16.50
How is the approved SmPC understood by the HTA Bodies and why does it matter
Beate Schäfer, BMS and Jan Müller-Berghaus, Paul-Ehrlich-Institut, CHMP Member
16.50 - 17.00
Discussion

SESSION 5:   APPROVAL OF DRUG-DEVICE COMBINATIONS

17.00 - 17.30

The trend in Marketing Authorisation Applications for biologicals covering drug-device combinations – how do we deal with them?
Ilona Reischl, Austrian Medicines and Medical Devices Agency, CAT member

17.30 - 17.45
Discussion
17.45
Close of day one
18.30
Bus departure to the social event
19.00
Social event

DAY 2, FRIDAY, 6 FEBRUARY 2015

08.00-08.30 Welcome coffee with snacks

SESSION 6:   UPDATE ON THE CLINICAL TRIAL REGULATION

08.30 - 09.00
Preparedness for the Clinical Trial Regulation in the EU - A company perspective
Surendra Gokhale, Roche
09.00 - 09.15
Discussion

SESSION 7:   UPDATE ON THE PRAC ACTIVITIES

09.15-09.45
Pharmacovigilance in the EU with emphasis on biopharmaceuticals – PRAC activities update
Post-approval efficacy studies
Doris Irene Stenver, Danish Health and Medicines Authority, PRAC Member
09.45-10.00
Discussion

SESSION 8:   SCIENCE AND STRATEGY OF DEVELOPMENT

10.00 - 10.30
Summary of the NC3R workshop held in June 2014: a future vision for non-clinical protein-based biotherapeutic development
Jennifer Sims, Integrated Biologix GmbH
10.30 - 10.45
Discussion
10.45 - 11.10 Coffee break
11.10 - 11.45 New treatments for Ebola or other emerging diseases outbreaks – how does the expedited pathway work to make them available to patients?
Michael Pfleiderer, Paul-Ehrlich-Institut, BWP Chairman
11.45 - 12.00 Discussion

SESSION 9:   LOOKING AT OTHER REGIONS: CANADA

12.00 - 12.45
Authorising biopharmaceuticals in Canada – pathways for biotech products, biologicals, vaccines, biosimilars and ATMPs
Jian Wang, Health Canada
12.45 - 13.00
Discussion
13.00 - 13.30
Coffee break and snacks

SESSION 10: NEWS IN CMC OF BIOPHARMACEUTICALS

13.30 - 14.15
Current topics discussed related to CMC of biopharmaceuticals
-QbD – is this reality for Biopharma?
-Critical findings in variations
-Requirements for CMC changes of biosimilars
Steffen Gross, Paul-Ehrlich-Institut
14.15 - 14.30 Discussion

SESSION 11: NEWER DEVELOPMENTS EXPECTED DUE TO CURRENTLY PENDING COURT CASES

14.30 - 15.15
Protection of Biological Medicinal Products – Latest Developments
- Data exclusivity: The concept of global MA under dispute?
- CHMP opinions regarding “new active substance” status
- Market exclusivity decisions
- Paediatric exclusivity decisions
- Supplementary protection certificates (SPCs): Biological substances as a challenge for national patent offices and courts
Geneviève Michaux, Hunton & Williams
15.15 - 15.30
Discussion
15.30
Wrap-up and concluding remarks
Chairs of the meeting
15.45
Close of the annual meeting