Over the past five years, the cosmetic industry has met with several legislative changes. Within the new legislative package, including the new REACH and CLP, it is important to find a comfortable routine that will minimize costs while staying effective and compliant with all regulations.
LatAm market rising in the eyes of pharmaceutical companies
Latin America is one of the emerging regions for the pharmaceutical industry. What are the top 5 reasons?
1. It is a fast-growing region, with fast-growing economies
According to Pharmtech, by mid-2016, the number of inhabitants in Latin America will rise to 625 million, more than six million above the estimated total population in mid-2015.
The leading countries according to VisionGain's report are Brazil, Mexico, Venezuela, Argentina, Colombia and Chile. Among the leading companies are Sanofi, EMS, Novartis, Pfizer and Bayer. Representatives from three of them are currently among our speakers.
2. Innovation, affordability and availability
Facilitation of market access is possible mainly because of the Agreement for Innovation, introduced in the second half of 2012. Companies in Latin America do a lot to work with governments and make sure innovation is available. Plus, about 78% of all medicines are paid for out-of-pocket in retail pharmacies.
3. The crisis did not have such an impact here
After the crisis, more restrictions and protectionist measures were generally imposed or enhanced, which had a negative impact for multinational companies. As pharma regulatory affairs consultant María Inés Guaia says, LatAm countries are pretty inelastic: a significant share of the pharma market is managed by national health authorities and social health insurance companies that didn't significantly cut expenditure in healthcare due to the crisis.
4. The trend towards standardized regulations is increasing
While each of the previously mentioned six major markets has adopted regulations that are based on Mercosur or PAHO recommendations, international health institutes and agencies like COFERPRIS are also pushing countries towards authorizations, certification and better consistency across countries.
5. Clinical trials and R&D
Currently, an estimated 4,000 clinical trials are being conducted. Discover the future of compliance in this rising market.
Be part of the event!
2nd Annual Pharmaceutical Compliance in Latin America Congress
Interested in this topic?
Advanced Protein Aggregation & Characterization
This training will focus on occurrence of particles in drug products, effects of protein aggregates, critical process and parameters. Attendees will gain overview of on utility and limits of predictive experiments, learn concerns from the authorities and relevant aggregation guidelines, and more.
CMC Analytical Comparability: Methods & Strategies for Biologics, Biosimilars & Biobetters
Attendees will be introduced to comparability in biosimilar development, the analytical strategies of protein characterization of biosimilars, the structure of proteins, in vitro pharmacology and much more.
Corporate Compliance & Transparency in the Pharmaceutical Industry
This two-day conference will serve as a platform for an open and dynamic dialogue with HCPs and patients to achieve common goals. Learn how to embed compliance in the business and develop one simple system for managing compliance & transparency in a complex and regulated environment.
Driving the national agenda of Medical tourism through PX Excellence
Read the interview with Dr. Layla Al-Marzouqi, Director of Medical Tourism Council at Dubai Health Authority, and learn how to enrich patient experience and quality of healthcare.
No more trouble with dangerous good shipments
Global temperature controlled pharmaceutical shipments are constantly faced with new logistics challenges and regulations. This January 2017, IATA Dangerous Goods Regulations added further complexity to shipping cold chain products compliantly.
5 Changes in Signal Detection Management
The European Medicines Agency, regulatory authorities in the Member States and marketing authorisation holders are responsible for detecting and managing safety signals. A safety signal is generally defined as information about a new or known Adverse Event that may have been caused by a medicine, where it is therefore necessary to conduct further investigation. Evaluation of safety signals plays a major role within pharmacovigilance. Therefore, it is vital for regulatory authorities to know the latest updates detailing the risks and benefits of medicines. The EudraVigilance database is an important source of information on suspected adverse reactions and signals.