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.
Interview: Project & Portfolio Management for Pharma & Biotech
Read the full interview with Eric Towler, Therapeutic Area Lead, BioPharma Project Management, Bristol-Myers Squibb and gain insight into the latest PPM trends.
1. What are the latest PPM trends occurring in the pharmaceutical/biotech industry?
The latest trend seems to be the huge diversity in what is expected of a “PPM” practitioner in any one organization. Current expectations range from your basic bread-n-butter, PMP-certified PM to someone who is officially leading R&D matrix teams or portfolio groups. The bread-n-butter PM of yesteryears is almost certainly not enough; this job role does still exist but is mostly a dead-end career that tops out at AD level or lower. The skill sets vary tremendously based on the organization. For the more leadership/strategic roles, the technical PM know-how may not be important at all. Whatever the technical/strategic requirements, EQ is as important as ever if not more. The bottom line is that the depth and breadth of knowledge required for overall marketability is more difficult than ever.
2. What are the main mistakes Product & Portfolio Managers tend to make and one should avoid?
Getting too comfortable in a role is a common mistake. It’s easy to do what you have done for years but you won’t learn much and you will certainly become less marketable.
3. What do you consider the most burning issue to be discussed at the upcoming 10th Annual Project & Portfolio Management for Pharma & Biotech – East conference?
There is no one burning topic as far as I am concerned. However, I believe it is an opportunity for practitioners to see gaps in their knowledge base and develop a plan to fill that gap.
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.