Bio Conference

Registration: Meet & Greet Networking Session with refreshments
13:00 - 13:30
Bio Conference: Networking
Chairperson Address: Chair Opening Remarks
13:30 - 13:40
Bio Conference: Keynote
Sr. Country Principal, Head of Consulting & Services
Turkey Local Guidelines & Incentives: Local guidelines, local incentives and government funding in Turkey
13:40 - 14:10
Bio Conference: Keynote
Turkİsh Medicines and Medical Devices Agency

- Understanding pricing in Turkey
- Understanding Molecules approval in Turkey
- Reducing the Information Gap on Biosimilar Medicines among Stakeholders
- Main incentives for Local Manufacturing
- What is in it for Turkish official and non-official stakeholders to invest in biotech medicine?
- What is R&D and investment incentives

Turkey Local Guidelines & Incentives: Biopharmaceuticals in Turkey - An industry perspective
14:10 - 14:40
Bio Conference: Keynote
Secretary General
Pharmaceutical Manufacturers Association of Turkey

- An analysis of Turkey's key assets in terms of knowledge base, infrastructure, and geostrategic location
- Biopharmaceutical market in Turkey
- Future projections that would increase the global competitiveness of Turkey

Bio Know-How & Value Proposition: Understanding the concepts of Biosimilars & Biobetters
14:40 - 15:00
Bio Conference: Keynote
Head of Specialty Care Division
Chimpharm, JSC with trade mark Santo Member of Polpharma Group

Understanding the concepts of Biosimilars & Biobetters, getting the know-how and main strategies to educate the local medical communities. Case study: From National to Common Pharmaceutical Market: biosimilars for the countries of the Eurasian Economic Union (EAEU).
- Biosimilars and biobetter concepts, harmonizing standards within the integrated region of the EAEU
- National and integrated regional developments in biosimilar medicines
- Updates, trends and current biosimilars market situations in different countries within the EAEU

Regulatory Strategies: Turkey Market Processes
15:00 - 15:20
Bio Conference: Keynote
Vice President of Medicines and Pharmacy
Turkish Medicines and Medical Devices Agency

Prioritization Processes of Pharmaceuticals in Turkey's Market

Coffee Break
15:20 - 15:50
Bio Conference: Networking
Regulatory Strategies: Gaining Early Approval in Different Markets
15:50 - 16:15
Bio Conference: Keynote
Principal Consultant and Managing Director
Woodley BioReg Limited

Regulatory strategies to gain early approval in different markets: understanding the U.S & EU approach compared to MENA region
- Main regulatory strategies to gain early approval in different markets
- New recommendations for biologics and Biosimilars from the European Medicines Agency (EMA)
- Updates from the US Food and Drug Administration (FDA) on biosimilars
- What MENA regulatory authorities need to start approving biosimilars quicker

Regulatory Strategies: Addressing IP Issues
16:15 - 16:35
Bio Conference: Keynote
Legal Advisor
Jordan FDA

Addressing IP issues, naming and labeling issues related to Biosimilars

Regulatory Strategies: Addressing Local Regulatory Challenges
16:35 - 17:50
Bio Conference: Panel Discussion
Expert at the National Center of drugs, medical devices and medical equipment
Ministry of Health and Social Development of the Republic of Kazakhstan
Legal Advisor
Jordan FDA
Country Manager
Astrazeneca, Ethiopia
Head of Management Consulting, Middle East and Africa
Deputy Director (Biological medicines registration)
National Department of Health, South Africa
Assistant General Manager / Secretary / Legal Advisor
Pasteur Institute of Algeria / Algerian Society of Pharmacy / Ministry of Health – Algeria

Addressing the main regulatory challenges in different regions and the uncertainty to work with Biosimilars.
- Local Regulatory Bodies approach and what can be expected from them when manufacturing Biosimilars
- UAE: new Healthcare Policies & Bio Pharma Regulatory Environment
- Bahrain National Health Regularity Authority approach to Biosimilars
- Ethiopia local polices & Regulatory aspects
- Jordan general perspective
- Algeria local aspects

Chairperson Address: Chair Closing Remarks
17:50 - 18:00
Bio Conference: Keynote
Sr. Country Principal, Head of Consulting & Services