All times displayed for Europe/Berlin timezone.

CPhI Theatre

The Future is Digital & What This Means for Pharma
10:30 - 11:00 CPhI Theatre, Hall 9 stand 9C80
Senior Consultant
[Cancelled] - Innovation in Pharma Logistics
11:10 - 11:40 CPhI Theatre, Hall 9 stand 9C80
QA RCR Director for MLEMEA
DHL Supply Chain
Accelerated Process Development: Role of Engineering Data Generation
11:50 - 12:20 CPhI Theatre, Hall 9 stand 9C80
Pharma Insight Briefings
Vice President and Head - Chemical Development
Syngene International Limited

Sponsored by:

The topic highlights the significance of engineering data generation to develop robust, safe and reproducible processes. The biggest challenge from a CMO perspective is to develop processes which are robust, scalable and reproducible across manufacturing environments and achieve right first-time. Developing a recipe for any process to achieve first time successful scale up requires adequate data collection within the phase appropriate development philosophy. The decisions made throughout the process development need thorough assessment supported by data to avoid surprises on scale. The most important success factors are the type and extent of data collection at each phase of development. It could be a reaction kinetics or a unit operation such as distillation, crystallization or drying or it could be an elaborate impurity purging study or DoE study to define parameter boundary or developing a transfer function. Over the years, Syngene has acquired significant expertise in generating engineering data at every phase of drug substance development supported with models and simulation. This has enabled us to consistently demonstrate seamless scalability and control over the processes compared to conventional approaches.

UC-II® Undenatured Type II Collagen for Joint Support
12:30 - 13:00 CPhI Theatre, Hall 9 stand 9C80
Pharma Insight Briefings
Business Development Manager - Consumer Health & Nutrition

Sponsored by:

Lonza’s UC-II® ingredient has been shown to support optimal joint health at low dosages, by improving comfort, mobility and flexibility.
Research recently published in Osteoarthritis & Cartilage provides further validation for Lonza’s UC-II® brand as a leader in the joint health ingredient space. The study demonstrated that UC-II® undenatured type II collagen diminished deterioration of articular cartilage in a rat model of osteoarthritis (OA).
The dose of the UC-II® ingredient selected for the study represents the clinically tested human equivalent dose of 40 mg per day. As this small size and once-per-day frequency provides an efficacious dose, it may improve consumer compliance.
UC-II® undenatured type II collagen has been shown to help improve joint comfort, mobility and flexibility in people with OA and is statistically significantly more effective than the combination of glucosamine and chondroitin, as measured by WOMAC.
With results showing 86% of respondents are concerned about the scientific proof behind the ingredients they consume, the UC-II® brand presents an ideal opportunity to create compelling, science-backed products that appeal to consumers’ evolving needs for joint health.

Selection of excipients for robust formulations
13:10 - 13:40 CPhI Theatre, Hall 9 stand 9C80
Pharma Insight Briefings
Managing Director
Nitika Pharmaceuticals

Pharma Forum Theatre

China: Entering the arena of European Generics
10:30 - 11:00 Pharma Forum Theatre, Avenida outside Halls 5 &6
Head - Global Generics
Sanofi India
What´s the new scenario for Biological Products and Biosimilars
11:10 - 11:40 Pharma Forum Theatre, Avenida outside Halls 5 &6
Head of Clinical Safety & Pharmacovigilance
Fresenius Kabi SwissBioSim GmbH
Regulatory insights & pricing in KSA
11:50 - 12:20 Pharma Forum Theatre, Avenida outside Halls 5 &6
Pharma Insight Briefings
Managing Director
Annahdah Mecical Co.

Sponsored by:

The Growth Path – Sub-Saharan Africa
12:30 - 13:40 Pharma Forum Theatre, Avenida outside Halls 5 &6
Panel discussion
Director, Generic Business
Yash Pharmaceuticals Ltd
CEO & Managing Director
Zenufa Laboratories (Tanzania) Limited
Co-Founder / Executive Director
DFS Africa Ltd

The session is designed as an introduction to the pharmaceutical market of Sub-Saharan Africa, and where the opportunities and challenges are for both local, and multinational players.

Innopack & P-MEC Theatre

Sustainable Development Goals 2030 in Pharmaceutical Packaging. Managing risks in the supply chain.
10:30 - 11:10 InnoPack & P-MEC Theatre, Hall 4 stand 4F121
Responsible for Chain of Custody&Brand development
Neuromarketing & Packaging: Keys from neuromarketing and packaging to make consumers fall in love
11:10 - 11:50 InnoPack & P-MEC Theatre, Hall 4 stand 4F121
Global Pharma Trends: Implications for the Packaging Sector
11:50 - 12:30 InnoPack & P-MEC Theatre, Hall 4 stand 4F121
Pharma Insight Briefings
Senior Consultant

Sponsored by:

New Options and Innovation in Healthcare Dispensing Systems
12:30 - 13:00 InnoPack & P-MEC Theatre, Hall 4 stand 4F121
Pharma Insight Briefings
Senior Global Commercial Director, Healthcare

Sponsored by:

New requirements for accurate dosing of liquid and suspension pharmaceuticals has driven the development of new and novel dispensing
systems and devices for known delivery pathways such nasal, topical and ophthalmic.
Patient preference, ease of use and ergonomics play a critical role today in the success of
pharmaceutical launches. Devices, therefore, must be developed with performance,
formulation compatibility and extensive consumer testing in mind. Patient adherence,
product repurchase, prescribing and differentiation can be all positively impacted when a
secure fit exists between the dispensing system, the pharmaceutical product, and patient

ICSE Theatre

Discussion Panel: Creating an Industry 4.0 strategy as part of your manufacturing plan to improve agility, minimize time and optimise manufacturing quality
11:10 - 11:50 ICSE Theatre, Hall 1 stand 1G90
Commercial Director
Global Consultores 4.0
Senior Manager Value Centred Design & Modelling
Serialization – Approach to Implementation and Execution
11:50 - 12:20 ICSE Theatre, Hall 1 stand 1G90
Pharma Insight Briefings
Director, EU Sales and Business Development

Sponsored by:

There are many barriers to entering into this complex service offering, and selection of the right partner is critical for success. This presentation will discuss challenges and complexities of serialization implementation and touch on the what, why and how of serialization.

CIS Market: Regulatory Strategies in Dynamic Convergence
12:30 - 13:00 ICSE Theatre, Hall 1 stand 1G90
Pharma Insight Briefings
Member of the Board
Inpharmatis, SIA

Sponsored by:

Break-through innovation in science and technology is rapidly changing the world of pharmaceuticals. In strictly regulated markets of the developed world there is a well-established structure within regulators allowing for the balance of availability of monitored for quality and safe innovative drugs to the patients. The situation in less developed with respect to regulatory scene countries is very different. Huge geographical region of CIS (Commonwealth of Independent States) representing ex-Soviet Union region and consisting of some twelve countries today is of great interest to pharmaceutical companies as one of the emerging markets. Penetration to these markets requires local knowledge of tendencies and problems. Many questions remain yet unanswered on GxP regulations, drug safety, regulatory aspects for biotech, radiopharmaceuticals, orphan drugs. However the convergence dynamics are obvious, allowing to predict the short-term future path of development and differences from the Western world. We present an analysis of the CIS market trends on regulatory affairs and drug safety for the upcoming years.

Polymeric innovations supporting drug delivery
13:10 - 13:40 ICSE Theatre, Hall 1 stand 1G90
Pharma Insight Briefings
Senior Manager, Field Development, Celanese Medical Polymers

Sponsored by:

The polymer industry has a significant role to play in the changing landscape of API delivery. Pharmaceutical industry ‘pain points’ such as injection site discomfort, incorrect usage of self- administered therapies, and side effects due to fluctuating blood serum concentrations, can all be improved by a focus on material selection for combination devices. This briefing will focus on 3 areas of focus:

1. Lowering the coefficient of friction for injection and inhalation devices.
2. Developing thinner, stiffer smart delivery device components to allow more space for increased device functionality.
3. Aligning our polymer excipient technology with evolving small molecule and biologic therapies.

Third party voluntary evaluation of APIs and intermediates
13:50 - 14:20 ICSE Theatre, Hall 1 stand 1G90
Pharma Insight Briefings
Deputy Secretary of China Chamber of Commerce for Import and Export of Medicines and Health Product

Sponsored by:

How third party systems of evaluation od APIs and intermediates applied for by manufacturers of APIs and intermediates help improving pharma supply chain in terms of better selection of supplies